Statistical Aspects Of Claims Substantiation

(MAXIMO C. GACULA & SINGH, 1998)

Claims on overall performance, liking, preference, and efficacy can be challenged through the Advertising Standard Council of India (ASCI), a self-regulatory system for the industry. Stated claims are supported by data that are statistically evaluated to judge if the experimental results are due to a real effect or to random variation. Therefore, before one can be translated into a statistical research hypothesis. If a claim cannot be translated as a research hypothesis, it cannot be substantiated.

Claims may be disputed for one or more of the following reasons:

• The experiment is poorly designed to address the claim.
• The experiment is poorly executed, i.e., protocol not strictly followed, unqualified personnel, and faulty instrumentation.
• The claim has no technical merit in relation to the product. Can the stated claim be related to product ingredients?
• Poor choice of methods for gathering the data, i.e., instrumental methods, use of consumer and/or trained panel. Is the method used following established guidelines, such as that provided by the Bureau of Indian Standards, Colipa guidelines for cosmetics, American Society for Testing and Materials, ISO standards etc?
• The statistical analysis is faulty. i.e., wrong methodology used.
• The stated claim is misleading.

Null And Alternative Hypotheses

A statistical hypothesis is a statement about the quantifiable aspects of products, which can be estimated from experimental results but are not otherwise directly observed. In statistical terminology, a research hypothesis (Claim) is called the alternative hypothesis. A complementary statement to the alternative hypothesis is called the null hypothesis. Statistical tests of significance are rules for judging whether the experimental results support the claim formulated as an alternative hypothesis.

Types Of Errors And The Power Of Statistical Test

Through experimental designs, data are collected and relevant sample statistics are computed, such as the mean, the standard deviation, etc. Since these statistics are subject to sampling and experimental errors, the statistical tests may lead to an incorrect decision. Suppose the decision is made to reject the null hypothesis and accept the alternative hypothesis. This decision, if it turns out to be wrong, is said to result in a type I error. The probability of type I error is denoted by α and is known as the significance level of the statistical test. A probability of α = 0.05 indicates that the test is liable to wrongly reject the null hypothesis 5 times in 100 cases. Significance levels α = 0.05 and 0.01 are often used in scientific applications and are generally the accepted levels for claims substantiations. On the other hand, a type II error results if the decision is made not to reject the null hypothesis but in fact it is false. The probability of type II error is denoted by ß. In the planning of a claim substantiation study, both types of errors should be controlled.

Statistical Significance | Experimental Significance

Statistical analysis is probabilistic. A statistically significant result may not be of practical significance to the consumers. For example, the colour of a cosmetic product may have changed over time from its original colour. The change may be statistically significant, but not necessarily in the eyes of consumers. Thus, instead of merely having a statically significant change, one may need to determine the amount of change that will be perceived as significant by the consumers. This amount of change must be determined by correlating trained panel results with consumer test results.

Types Of Claims

Claims may be classified by two properties: style and competitive focus. Style refers to the statement being made about the advertised brand, the most common being a “distinction” claim, in which a brand claims to be preferred, more efficacious, safer, etc. Another style is a “similarity” claim, which conveys that the advertised product is like the competitor’s product in one or more attributes. All products in this category must be tested against the advertised product.

A competitive focus claim is a statement being made about the competition against one or more explicitly identified brands or implied brands. For example, the claim may be targeted against an implied brand, i.e., “preferred over the leading brand.” or more broadly against a brand set, i.e., “No leading oil is more absorbent.”

In both style and competitive focus, a claim statement can be monadic, making no comparison with other products, i.e., a statement of quality, an invitation to try the product or an untargeted claim. An untargeted claim is considered puffery and requires no formal substation.

Models For Analysis Of Product Performance Data

A useful model for the evaluation of a proposed claim must address the following aspects:

• Rationale,
• Objective evidence,
• Subjective evidence, and
• Safety

A model incorporating these aspects becomes increasingly important in disputed claims.

Rationale

Consumer products contain ingredients that affect the perception that they are desirable. By linking ingredients in a product to experimental results, one can provide a rationale for the claim. Experimental support from allied sciences, such as in-vitro studies and model systems, can also provide additional rationale for the claim.

Objective

A claim becomes stronger if its usefulness can be objectively and subjectively determined. An objective measure of product performance is desirable. It can be obtained by clinical studies in real-life settings on humans and the targeted population per product. Responses from such clinical studies can be measured by bio instruments or obtained by trained or expert panels. Indeed, data from trained panels are recognized as objective measures. Descriptive analysis and the spectrum method, which used a trained panel, can provide objective measures of the sensory properties of personal care products.

A descriptive panel undergoes rigid training and validation/calibration as specified by each method.

Subjective

When properly carried out, subjective measures obtained from home use testes, among others, may provide useful and acceptable data for claims substantiation.

Safety

Obviously, cosmetics products must be safe and without adverse side effects. The model must address the safety aspects. Safety-related data can be obtained from research guidance panel tests, central location consumer tests, and the various types of laboratory model systems, i.e., in vitro and in vivo tests.

As indicated, a model incorporating these aspects provides a way to deal with conflicts, permits more efficient use of data for the development of truthful claims, and promotes effective communications between parties in disputed situations.

A conceptual model for assessing perception data measuring interdependent attributes is postulated, this model defines the following:

1. Whether the product performance claim is based on a product attribute or not i.e., the emphasis is on overall product performance with no focus on product attribute or benefit.
2. Whether the product performance claims focus on a specific attribute or on a set of attributes i.e., drag, stickiness, residue, spreadability.
3. Whether the claim is for a specific attribute or a set of attributes and whether it focuses on a feature or a benefit. For example, in antibacterial personal care products, the active ingredient provides a product dimension and the benefit of this dimension is cleanliness and safety to the users against bacterial infection.
4. Whether the claim is merely stating the presence of the attribute or also its benefit and whether it suggests a parity or superiority against a specific competitor or class of competitors.
5. Finally, whether the parity or superiority claim is restricted to an attribute and its advertised benefits or to an overall parity or superiority. For example, in consumer tests, an overall preference or overall liking when used as a claim suggests that all product attributes contribute, incorporating interdependence among sensory attributes during product evaluation by consumers.

The experimental designs suited for obtaining data for parity and superiority claims are discussed further on.

Superiority Claims

A superiority claim simply indicates that the product advertised is the best in the market. It is essential that direct product-to-product comparative testing be used for substantiating a superiority claim. An appropriate design for comparing two products at a time is known as the paired-comparison design. Which is discussed further on. An example of a superiority claim is “compared to the leading brands, tropical Isles is unsurpassed as a skin moisturizer and conditioner” As stated before, a claim must be translated into a statistical hypothesis. In order to do this, we must have a well-defined scale on which these products can be scored for comparison. Suppose product A is being compared with a leading brand for claim substantiation. If, on a scale for comparing such products, high scores correspond to superior products, we can formulate two statistical hypotheses such as the following:

H0: Average score of leading brand   average score of product A

H1: Average score of leading brand <average score of product A

To be able to claim superiority for product A, the null hypothesis must be rejected at, say, the 95% confidence level (5% significance level) in favour of the alternative hypothesis, which states that product A is superior to the leading brand.

Parity Claims

Parity claims are difficult to establish by means of hypothesis testing methodology because for parity claims the research hypothesis essentially states that the products are equivalent. Using a rating scale, the equivalency is translated as equality of two average scores, equality of average scores can only be stated as the null hypothesis. A statistical test will either reject the null hypothesis when there is sufficient evidence in support of the alternative or will not reject it. If the null hypothesis is not rejected, it should not be understood that the products are equivalent. Intentionally or otherwise, one can design an experiment to collect insufficient data, lacking information that leads to a decision not to reject H0. This decision only means that there is insufficient information to disown the parity claim. it does not mean that a parity claim is established with any degree of confidence.

In disputed parity claims, if a proper formulation of hypotheses and a sound design are not used, differences may arise that will be difficult to resolve among the parties involved. It is a waste of time to argue about the validity of a claim if the methodology and the design are not carefully employed. As stated above, one can design an experiment with an insufficient sample to mask significant differences between products because of the failure of the study to reject the null hypothesis. Every experiment may be said to exist only in order to give the facts a chance of disproving the null hypothesis”.

Therefore, the formulation of hypotheses for a parity claim and their statistical testing must be done in such a way that the decision to reject the null hypothesis amounts to the parity of products.

Experimental Designs For Claim Support

There are three important elements in the development of a strong product claim:

• A clearly stated claim,
• A good experimental design to address the claim, and
• A properly executed study following the experimental design. A critical part of the first element is the specification of the target population, because once this is done, the development maire development, sample size, test execution.

Target Population

A product is developed to meet either the needs of the general population or those of a specific user group in the population. Depending on the stated claim, the general population or a specific group defines the target population. In particular, the user of the product could be the purchaser and not necessarily the user. For instance, the wife is the purchaser of baby powder. on the other hand, the husband is the purchaser of after-shave skin conditioners. In the first case, wives would be the target population, and in the latter case, husbands. If the claim is for the general population, then the participants in the test would be a random sample of the population. Similarly, a random sample of a specific user group should be used in the study.

Questionnaire Design

In gathering consumer data for claim substantiation, it is important that the product attributes related to the claim be included in the questionnaire. For example, if “soft” and “smooth” are sensory attributes claimed for the product, then these attributes must be included in the questionnaire in the form of intensity and /or hedonic (like/dislike) questions.

How many attributes questions the questionnaire should include is often a difficult decision to make in questionnaire development. If a product has undergone a series of descriptive sensory analyses, this should provide the appropriate number of attributes for inclusion. Briefly, descriptive analysis is a sensory methodology that provides quantitative descriptions of products based on the perceptions of a group of qualified subjects. It is a total sensory description, taking into account all sensations perceived—visual, auditory, olfactory, kinesthetic, and so on – when the product is evaluated. In practice, the desirable number of attributes has ranged from 10 to 15.

Another aspect of questionnaire development is the choice of the rating scale (1=dislike extremely, 5=neither like nor dislike, 9=like extremely) developed in 1947 at the Quartermaster Food and Container Institute for the U.S. Armed Forces. This is the most extensively studied of rating scales and, as a result, is the most reliable one for acceptance/preference measurement. Information on questionnaire development is widely available.

Paired Comparison

The paired comparison is the most powerful design to support almost all types of product claims. The statistical analysis of paired-comparison design is simple and meets all the essential statistical assumptions; the test is simple to execute for both the experimenter and the panellist, and the evaluation of two products by a single panellist, and the evaluation of two products by a single panellists first nicely into the classic paired-comparison situation (i.e., right/left sides of biological materials.)

The general idea of the paired-comparison design is to form homogeneous pairs of like units so that comparisons between units of a pair measure differences due to treatments rather than units. This arrangement leads to dependency between observation on units of a pair measure difference due to treatments rather than units. This arrangement leads to dependency between observations on units of the same pair. This situation can be extended to sensory and consumer testing. The statistical assumption in the analysis is that the differences is independent and normally distributed; in most cases this assumption is satisfied in practice. Furthermore, the common problem of correlation of ratings among panelists becomes irrelevant, since one is now dealing with differences di.

Randomized Complete Block Design

For reasons of cost, time, and other business constraints, one must conduct a consumer test with more than two products for evaluation by panelists at the same time. In this situation, the randomized complete block design (RCBD) is used for claim substation. The statistical model for describing an observation is

yij=µ+Ai+Bj+eij

Where = the observed rating for the  product given by the  panelist; µ= the grand mean; = the effect of the  product; = the effect of the panelist; and = random errors assumed to be independently and normally distributed, with mean zero and variance . In this model, the effect of panelist-to-panelist variation is removed from the random errors  , making the test of significance more sensitive.

In most consumer testing claim studies, the statistical analysis from the RCBD or the single-factor repeated- measures design is sufficient. Also, the SAS code in table 5 can easily be expanded to include demographics, product usage information, and so on.

Concluding Remarks

We have covered the importance of statistical experimental design to consumer tests for supporting claim substantiation. In particular, the formulation of statistical research hypotheses is discussed and its importance in parity claims reviewed. The use of a paired-comparison design is recommended for claims substantiation. The importance of understanding the power of a statistical test and its relationship to sample size to provide a claim that can withstand rigorous scrutiny was emphasized.

Bibliography

Maximo C. Gacula, J., & Singh, J. (1998). Consumer Testing Statistics and Claims Substantiation. In L. B. Aust, Handbook of Cosmetic Claims Substnatiations (pp. 235-258). New York: Marcel Dekker, Inc.

New Developments In Understanding Of Sensitive Skin

Sensitive skin is a condition of subjective cutaneous hyperreactivity to environmental factors. Subjects experiencing this condition report exaggerated reactions when their skin is in contact with cosmetics, soaps, and sunscreens and they often report worsening after exposure to dry and cold climates.

Recent findings support the connection between skin microbiota and sensitive skin. Neurohormones diffuse in sweat and epidermis leading skin bacterial microflora to be largely exposed to these host factors. Bacteria can sense a multitude of neurohormones. Substance P (SP) is stimulating the virulence of Bacillus and Staphylococci. The action of SP is highly specific with a threshold below the nanometer level. In a recent study of the mycobiome of sensitive skin was more phylogenetically diverse than that of non-sensitive skin. Lactobacillus and Mucor racemosus were more abundant on sensitive skin than nonsensitive skin, whereas Malassezia restricta was less abundant. Both skin microbiome and mycobiome varied according to the perceived skin sensitivities of the subjects.

Sensitive skin is not limited to the face and the scalp is an area frequently involved: sensitive scalp showed disrupted barrier function, abnormal sebum amount and composition, as well as the perturbed microbiome, which might be the direct cause. The role of microbiome and mycobiome in sensitive skin needs more investigation as well as the possible neurogenic alterations. A complete understanding of this peculiar syndrome may lead to the development of new and more effective pharmacologic and cosmetic treatments.

Bibliography

Misery, Laurent. 2023. “Sensitive Skin Testing.” In Handbook of Cosmetics Science and Technology, by Elsa Jungman, Kazutami Sakamoto, Howard I. Maibach Frank Dreher, 182-189. Boca Raton, London, New York: CRC Press.

Baby Care Products For Skin And Hair

The primary care products that come in contact with baby skin are diapers and cosmetics. Baby cosmetics can be mainly subdivided in two groups, namely cleansing and protecting cosmetics. Recently there is an increase in baby care products that contain natural ingredients or fewer ingredients, however non-all-natural products like certain plant extracts, are recommended to be used on skin. Certain ingredients like perfumes, could lead to skin reactions and should be avoided in baby products, unless considered safe for use on baby. Other ingredients, like preservatives make sense in products where microorganisms can be a risk, like in aqueous based products.

When formulating products there are several factors that need to be considered and it is recommended to work together with experts like toxicologists and microbiologists to ensure the product is safe to use on baby skin. Some ingredients may also be prohibited or restricted in certain countries and experts need to be consulted to ensure that the product is allowed to be marketed and sold in that country.

Hygiene Products: Diapers

The most appropriate strategy for diaper rash is prophylaxis, including keeping the skin clean and dry. Introduction of superabsorbent polymers is used to turn urine into gel. These are absorbent particles that can absorb huge amounts of liquid and therefore help keep the diapers thin but highly absorbent.

Cleansing Cosmetics

Surfactants and Soaps:

Bathing a baby for 5-7 minutes in lukewarm water (35-36°C) usually is sufficient. Better is to use so-called secondary tensides, including nonionics and amphoterics, or mild anionics such as sulfosuccinates, isethionates, and protein fatty acids condensates.

The use of bath foam is not suitable for babies because of its high content of primary tensides producing excessive foam. Parents often think that foam is important for its cleansing properties but foam has no cleansing function, and the ingredients required to produce a sufficient amount of stable foam are often quite irritating and not suitable to be used in baby shampoo, e.g., alkyl sulfates, and alkyl ether sulfates.

Emulsions and Oils:

For cleansing of the baby and in particular the diaper zone, liquid cleansers based on oil-in-water (o/w) emulsions are often used, especially when water and washcloth are not well tolerated by the baby’s skin.

When a baby is prone to contact dermatitis, it is advised to screen the ingredients list because those tissues often contain high concentrations of preservatives, necessary to prevent microbiological contamination of the tissues.

Baby Wipes

Over the last two decades disposable baby wipes have been developed as an alternative to traditional cleansing methods. Wipes consist of a nonwoven carrier material soaked with an emulsion-type, watery or oily lotion. Cleansing studies confirmed that high-quality baby wipes are suitable for daily cleansing of the diaper area, of healthy babies as well as of babies with comprised, irritated skin, on newborn infants and on atopic and premature populations. A cleansing baby wipes with sufficient pH buffering capacity offers an opportunity to stabilize skin pH at physiologic levels and thus help to overcome the potentially detrimental effects of an elevated skin pH in the diaper area.

Protecting Cosmetics

Emollients/Lotions

In good skin care of diaper zone, the application of emollients plays an important role, and the application of a cream layer can create an effective protective barrier. Protective emollients like petrolatum for the nappy zone are preventive or protect the skin against aggressions from urine, feces, and their interactions. Zinc Oxide (ZnO) is an often-used component in diaper rash protection products but may be considered a cosmetic or drug depending on the country. Allantoin, alpha-bisabolol, Aloe vera extract and silicones can be added to improve water resistance.

Powder

Talc powders are not often applied anymore in the diaper area. They absorb moisture, decrease maceration and help prevent irritation of the baby skin. Talc is susceptible to contamination with microorganisms and needs sterilization.

Bibliography

Susanna Brink, M. O. (2023). Baby Care Products. In E. J. Frank Dreher, Handbook of Cosmetic Science and Technology (pp. 339-340). Boca Raton, FL: CRC Press.

Safety Considerations For Baby Care Products

To bring safe baby cosmetics on the market, risk assessment is a key priority and often includes a broadly recognized iterative four-step quantitative exposure-based risk assessment process (US National Academy of Sciences, WHO and the European Union’s Society Scientific Committee on Consumer Safety and Bureau of Indian Standards IS 4011:2018.

The potential impact of skin irritation on dermal absorption should be taken into consideration during baby cosmetic product development.

A distinction should be made between intact, healthy skin and the potentially damaged skin of the nappy zone for which risk factors exist, which are not present for the rest of the body.

The increased prevalence of allergic contact dermatitis in children has prompted scrutiny of products marketed for neonates and children for the presence of sanitisers.

Criteria

During the development of baby products, a number of criteria should be taken into consideration:

• High quality of raw materials in terms of purity, stability, and microbiology via appropriate Certificate of Analysis (CoA).
• Skin Irritation, which is dose-dependent, can be controlled by avoiding well-known irritative ingredients and/or reducing the concentration or frequency of application.
• The presence of sanitizing molecules such as perfume ingredients, even when IFRA (International Fragrance Association) – tested and/or excluding the 26 allergens taken up in regulations, should be avoided if they are not found to be safe.
• The product information file of baby cosmetics, safety data of all ingredients and the finished product, together with a dedicated risk assessment, carried out by a safety assessor, should be present. It should be indicated what specific measures have been taken for baby skin.
• Special attention should be given to the concentration of (i) reactive substances (ii) promotional additives, ‘natural’ and ‘exotic’ ingredients, complex mixtures, plant extracts and animal-derived ingredients or any ingredient from a questionable, impure source; (iii) potential allergens, penetration enhancers, aggressive organic solvents, highly detersive or foaming agents, and antiseptics in particular in daily use products; and (iv) concentrations of preservatives.
• Good practice is: (i) to protect unsaturated lipids from oxidative reactions by adding anti-oxidants; (ii) to adjust and buffer the pH of the final product to skin-friendly pH between 4.5 and 6; (iii) to add chelating or sequestering agents to prevent heavy metal precipitation and protect the preservative system; and (iv) to use known protective skin barrier ingredients.

Dermal Absorption

Dermal absorption data is compound-dependent, varying molecular weight, hydrophobicity
| hydrophilicity, structure, etc., and frequently determined using adult skin.

• The surface area | body weight ratio is 2.3-fold higher in newborns than in adults decreasing to 1.8-fold at 6 and 12 months, respectively. Application of the same amount of product on a similar body surface of baby versus adult could result in higher blood and tissue concentrations in the newborn.
• Pharmacokinetic parameters differ widely between babies and adults and result in reduced clearance and/or a longer half-life of bioavailable substances, thus increasing the potential risk for adverse reactions in babies. Concerning the total body water content, it is known that infants have a higher water content (80-90%) compared to those of adults, which steadily decreases to 55-60%

Another pharmacokinetic difference is a decreased protein binding capacity which can be linked to lower concentrations of glycoproteins in the plasma of infants.

Full-term neonates, tend to show a three to nine times longer pharmacokinetic half-life than adults.

• The SC thickness is reported to be the rate limiting part for percutaneous penetration and thus dermal absorption. The SC is thinner in baby versus adult skin, as measured by confocal laser scanning microscopy, and needs to be considered. The path that molecules have to follow to penetrate the SC layer is potentially shorter.

Importantly, the SC’s barrier is functional at birth and matures for many key skin characteristics (skin pH) in the first few months after birth.

• In use conditions of topical products also play a role. Cosmetic skin care products often are applied onto large body surfaces, e.g., cleansing lotions, sunscreens, etc., increasing not only the potential risk for local effects but also dermal absorption and potential systemic toxicity. This factor is considered in exposure-based risk assessments.
• The Diaper Area and non-diapered regions are indistinguishable at birth but show differential behavior over the first 14 days, with the diapered region having a higher pH and increased hydration. Innovative hygiene absorbent and baby care products, however, provide an increasingly good skin compatibility profile, making the frequency and severity of DD decline.
• Other important factors for dermal absorption are SC hydration and skin pH. For instance, differences in skin pH change the ionization grade of molecules and will influence dermal absorption.

Bibliography

Susanna Brink, M. O. (2023). Baby Care Products. In E. J. Frank Dreher, Handbook of Cosmetic Science and Technology (pp. 339-340). Boca Raton, FL: CRC Press.

Sensitive Skin Testing

(Patel 2021) (Misery 2023)

The evaluation of sensitive skin is useful for assessing the effectiveness of certain products. The “International Forum for the Study of Itch (IFSI) defined sensitive skin as follows: “A syndrome defined by the occurrence of unpleasant sensations (stinging, burning, pain, pruritus, and tingling sensations) in response to stimuli that normally should not provoke such sensations. These unpleasant sensations cannot be explained by lesions attributable to any skin disease. The skin can appear normal or be accompanied by erythema. Sensitive skin can affect all body locations, especially the face.

In a meta-analysis, cosmetics and physical (variations in temperature, cold, heat, wind, sun, air, conditioning, wet hair and dry hair), chemical (water and pollution) or psychological (emotional) factors are associated with sensitive skin. The most important factors are cosmetics, air conditioning, heat, and water).

The global prevalence of “Sensitive Skin” is approximately 50% with variations among some countries.

According to the high frequency of sensitive skin, a single pathophysiological mechanism is debatable. However, a growing body of data supports the hypothesis that sensitive skin is a neuropathic disorder.

Reactivity Tests​

• Stinging Test

The famous lactic acid stinging test (LAST) of Frosch and Kligman is the first standardized test. It consists of the application of 0.5 mL of 10% (or 5%) lactic acid to the nasolabial fold with subsequent assessment of the severity of the subjective symptoms. Erythema is evaluated. Control is provided by the application of a saline solution to the other fold. This test is very commonly used and is very useful for follow-up. (Maheshvari N Patel n.d.)

• Capsaicin Test

A 0.075% emulsion of capsaicin is applied. Similar to the LAST, it could have been controversial since involving the use of a subjective individual pain scale as well and it induced too painful sensations in very sensitive skin subjects.

Additional Tests

The aim of other tests is to evaluate skin properties which can be modified in subjects with sensitive skin but are not directly related to sensitive skin. Hence, the measurement of structural or physiological cutaneous changes after the application of topical irritants can be performed: Trans Epidermal Water Loss (TWEL), cutaneous pH, and epidermal thickness, measured by ultrasonography, optical microscopy, or confocal microscopy, as well as skin penetrability, assessed with UV light, can be studied parameters. Recently, the use of confocal Raman microspectroscopy was proposed to analyze the molecular composition of stratum corneum and consequently the modifications of the skin barrier in sensitive skin. All these tests are commonly used in studies on sensitive skin, but they do not measure skin hypersensitivity.

Questionnaires

• Sensitive Scale

*Sensitive scale (SS-10) is a 10-item scale. Correlation with the dry skin type, higher age, female gender, fair phototypes, and the Dermatology Quality of Life Index (DLQI). DLQI is a tool to evaluate the quality of life in patients with skin disorders.

Skin Irritation

*Important to be completed by the Patient.

Using a vertical line, indicate the symptoms felt during the past 3 days on the horizontal line (0=absence of irritation, 10 = intolerable irritation)

Skin Condition Felt

• Tingling
• Burning
• Sensations of heat
• Tautness
• Itching
• Pain
• General discomfort
• Hot Flashes

Visible skin condition

• Redness

• 3S Questionnaire

The total score can be obtained by multiplying score severity of abnormal sensations by the number of these sensations. The 3S questionnaire allowed discrimination between subjects with slightly sensitive, sensitive and very sensitive scalp. Itching and prickling are the most frequent symptoms. The 3S questionnaire is a convenient and effective tool for investigating the severity and symptomatology of the sensitive scalp.

• BoSS Questionnaire

The BoSS questionnaire is designed to evaluate all these aspects in patients with sensitive skin. This questionnaire was developed using standardized methods for creating and validating quality-of-life questionnaires, consisting of three phases: a design phase, a development phase, and a validation phase.

Conclusion

A large number of techniques for sensitive skin testing suggests that the authors may try to find a technique for the diagnosis of sensitive skin. In any case, all these subjective and objective tools for sensitive skin testing can be used in comparative studies, especially those that evaluate the efficacy and/or safety of cosmetics and cosmeceuticals.

Bibliography

• Patel, Maheshvari, Gajjar T, Patel N, et al. 2021. “Enhanced efficacy of radiant skin serum in subjects with moderate to severe dry and sensitive skin.” Journal of Dermatology and Cosmetology (MedCrave) Volume 5 (Issue 1): 6-11.
• Misery, Laurent. 2023. “Sensitive Skin Testing.” In Handbook of Cosmetics Science and Technology, by Elsa Jungman, Kazutami Sakamoto, Howard I. Maibach Frank Dreher, 182-189. Boca Raton, London, New York: CRC Press.
• Maheshvari N Patel, Apeksha Merja, Nayan K Patel. n.d. “Standardization and Validation Study for Methods Used for Patch Testing.” Inventi Journals (P) Ltd (Inventi Rapid Clinical Research) 2022 (1): 1-4.

Fundamental of Real-World Evidence Studies

The healthcare industry has been relying on traditional research approaches for a long time, but the information gained from these methods often needs to be expanded in scope.

Real-world evidence studies have the potential to provide new insights into clinical interventions and patient outcomes, giving us a clearer understanding of what works best in different scenarios. Read on to find out why This type of research is essential for making informed decisions in the healthcare sector.

There are several benefits of conducting Real-World Evidence (RWE) studies. RWE can provide insights complementary to traditional clinical trials and help generate new hypotheses about the safety and efficacy of treatments. RWE studies can also be conducted at a fraction of the cost and time of clinical trials, making them an attractive option for drug developers.

Challenges of RWE Studies

There are many challenges associated with conducting real-world evidence studies. First, it can be difficult to identify and enroll appropriate study participants. Second, data collected in the real world is often of lower quality than data collected in controlled clinical trials. It can make it difficult to draw reliable conclusions from real-world evidence studies. Third, real-world evidence studies are often conducted on small samples of patients, which can limit their statistical power and generalizability. Finally, the results of real-world evidence studies can be confounded by numerous factors, such as patients’ baseline characteristics, concomitant medications, and health status at the time of data collection.

Types of RWE Studies

• There are three types of RWE studies: observational, interventional, and hybrid.
• Observational studies are conducted using data already collected, such as from patient registries or electronic health records. These studies can be retrospective (looking back at past data) or prospective (collecting new data).
• Interventional studies involve actively intervening in the care of patients to collect data. These studies can be randomized controlled trials (RCTs) or non-randomized studies.
• Hybrid studies combine elements of both observational and interventional designs. For example, a hybrid study might use data from a registry but also include a component where patients are actively followed over time.

How to Design a Successful RWE Study

There are a few key things to keep in mind when designing a Real-World Evidence (RWE) study:

1. Define your study population and target disease or condition. It will help you determine what data sources to use and how to select your study subjects best.
2. Create a robust data collection plan. It should include specifying which data sources you will use, how you will collect the data, and how you will clean and prepare the data for analysis.
3. Develop clear hypotheses and objectives. Your RWE study should answer specific questions about the effectiveness of treatments or interventions in the real world.
4. Plan for statistical analysis and power calculation. It will ensure that your RWE study is powered to detect meaningful treatment effects.
5. Write a detailed protocol for your RWE study. The document should outline all study aspects, from eligibility criteria to primary and secondary outcomes.
6. Work with experienced partners. Conducting an RWE study can be complex, so it is important to partner with professional organizations or individuals who can help you design and implement the study successfully.

Conclusion

Real-world evidence studies provide invaluable insights into the effectiveness of treatments and therapies in real-world settings. They are an important part of healthcare decision-making, as they can inform decisions that lead to improved patient outcomes. We hope The article has helped you understand the importance of conducting RWE studies and how they can be used effectively in clinical practice. With their help, health professionals can better serve their patients by providing the best possible care based on reliable data.

Ceramide and its metabolites (sphingosine, 4-hydroxy-dihydro sphingosine (phytosphingosine), sphingosine-1-phosphate (S1P) phytosphingosine-1-phosphate and ceramide-1-phosphate (C1P) are lipid mediators that modulate cellular function.

Ceramides and structural pseudo ceramides have been formulated in skin care products and medicine to treat xerosis, psoriasis, atopic dermatitis (AD). Topically applied ceramide, with appropriate chemical formulation, forms stable liquid crystal and bilayer structures, improving permeability barrier integrity on the skin surface. Ceramide may be incorporated into lamellar bilayer structures to enhance barrier integrity in the stratum corneum. It is noted that as changes in ceramide species occur in AD and psoriasis, ceramide species uses for topical agents must be carefully considered. Acylceramide is a ceramide species essential for forming a competent barrier. A suitable selection (and amount) of ceramide is required for the preparation of an effective topical formula. Topically applied ceramide can penetrate into nucleated layers of the epidermis, in particular in barrier-compromised skin. Absorbed ceramide is hydrolyzed to a sphingoid base and FA, which are utilized in endogenous ceramide synthesis.

Oral glycosylceramide and sphingomyelin derived from plants and milk are used (as nutraceuticals) to improve skin moisture and the epidermal permeability barrier. Some oral sphingolipids are hydrolyzed by digestive enzymes and enzymes derived from intestinal microbes and absorbed through the intestinal membrane. Sphingolipids could affect gut immunity. Absorbed sphingolipids are transferred to the liver where they are further metabolized and circulated to peripheral tissues, including skin.

Source: (Uchida)

Clinically Proven” Claim – Scientific Indication

Scientific indications are usually supported with clinical data from relevant human studies that have likely undergone some scientific assessment or scrutiny. Due to this quantifiable scientific research undertaken into their mode of action and/or health benefit, this evidence type is appropriate to support efficacy for your listed medicines/products.
The claim ‘clinically proven’ has become very in demand with marketers of both therapeutic and cosmetic products. This is likely due to the fact that this claim may provide consumers with greater confidence in their choice of products.
In reality, despite the fact that ‘what’ has been clinically proven is not often disclosed, stating that the product is clinically proven suggests that there are proven benefits in using these products, which is enough to influence some consumers to choose these products over others. This is because common consumers might understand a product as having better efficacy, higher safety, or more reliable results.
The word ‘clinical’ refers to the fact that the product has undergone one or more clinical trials, which are clinical studies conducted by a qualified research team in a controlled, scientific unbiased manner. The power of the scientific method is that one can be certain any results obtained are not due to external or uncontrolled factors, and if documented properly, such an experiment is repeatable for anyone wishing to independently verify the results.
The word ‘proven’ means that in the clinical trial(s), the results obtained have been demonstrated to be statistically significant. This means that one can be fairly confident that the results of the product and a test comparator were not obtained due to random variance (chance), or other extraneous factors.
For complementary medicines, the TGA (Australian Government) has some guidance on the use of this term, on their website stating that “…These terms are not acceptable unless supported unequivocally by robustly designed, published peer-reviewed clinical trial(s) conducted on the actual medicine being advertised, or an identical formulation and dose (as a minimum)”. For cosmetic products, the lack of guidelines for the use of claims such as clinically proven might have contributed to some common misconceptions.
The use of the term ‘clinically proven’ in scientific indication infers a level of certainty in the implied health benefits associated with the listed medicines/products in that it has been clinically trialled and proven to be effective. These terms are not acceptable unless supported unequivocally by robustly designed, published peer-reviewed clinical trial(s) conducted on the actual medicine/products being advertised, or an identical formulation and dose (as a minimum). The use of the terms ‘clinical’, ‘clinically’, and ‘scientifically’ coupled with ‘trialled’ or ‘tested’ implies a higher level of certainty associated with the health benefit of your medicine/product and unless matched by well-designed series of clinical studies on your specific medicine/product, may mislead consumers about the effectiveness of your medicine/product.
You must compare your indication with the quoted health benefit in your evidence identified from scientific sources. Your indication will refer to the same clinically significant study outcomes as that reported in the clinical study.
In selecting your scientific indication you should:

• ensure that the medicine’s/product’s therapeutic benefit is demonstrated by the clinical study outcomes
• ensure that any claims you make from your medicine/product imply only the same level of certainty in clinical effectiveness as that reported in clinical studies, for example ‘clinically proven to…’ compared to ‘may assist to…’

Source: (Administration, 2019)

Sunscreen – Complete Sun Protection Strategy

Recurrent exposure of the skin to the sun could result in short-term as well as long-term changes in the structure of the skin. In short-term effects, repeated exposure leads to erythema, whereas repeated exposure in the long term could cause irreversible loss of skin elasticity and the development of melanomas and non-melanomas. Photoprotective agents like sunblocks or sunscreens prevent and reduce the damaging effects of ultraviolet (UV) light.

There are two significant ways that sun exposure can damage your skin health: ultraviolet A (UVA) radiation, which speeds up the aging process in your skin, and ultraviolet B (UVB) radiation, which burns your skin cells. The UV rays from the sun can reach your skin not just when you are outside but even when you are inside your home or car through the windows.

The skin has its natural defense mechanisms to protect it from UV radiation at a certain level. But, it’s insufficient to shield your skin cells from excessive sun exposure, which can result in long-term skin concerns such as age spots, wrinkles, pigmentation, sagging, skin, roughness, darkening, and others.Hence, it is essential to use Sunscreen daily, which acts as a barrier on your skin against sunlight.

Why to use Sunscreen?

The use of sunscreens for protection against the damaging effects of sun rays has been on the rise for years. They have been widely used for their photo protective properties, including the prevention of photocarcinogenesisand photo aging, as well as for the management of photodermatoses. Regular daily use of SPF 15 sunscreen can reduce your risk of developing squamous cell carcinoma (SCC) by about 40 percent, and lower your melanoma risk by 50 percent.

5 W’s and H of Sunscreen:

Who Should Use: Everyone Under the Sun!

Why to Use: Reduce your risk of skin damage and skin cancer!

When to Use:Every day! 30 minutes prior to going outdoors. Reapply every two hours even in winter.

Where to Use: All exposed Skin!

What to Use:Broad spectrum SPF 15 or higher; SPF 30 or higher for a day outdoors!

How to Use:One ounce to the entire body for each application!

**Protected Skin is always in**

Significance of Biotin (Vitamin B) – Supplement for Women with Polycystic Ovary Syndrome.

Polycystic ovary syndrome (PCOS) is one of the most common reproductive abnormalities, affecting 5% of the population of reproductive-aged women, is a multifaceted metabolic disease linked with insulin resistance (IR). Women with PCOS produce higher-than-normal amounts of male hormones (Androgens) in the body leading to multiple problems. The exact cause is unknown, but this hormone imbalance causes their body to skip menstrual periods and makes it harder for them to get pregnant. Genetic, Environmental factors; especially nowadays poor diet, and a sedentary lifestyle are the main reasons for PCOD in women. Every 1 in 10 Indian women suffers from PCOD. However, still women are not aware of PCOS/PCOD. It is vital that every woman should know the symptoms so that they can be identified, and treatment can be sought immediately.

Some of the common symptoms involved in PCOS are as follows. In PCOS the arrested follicles (egg sacs) give a typical appearance on ultrasound. The name polycystic ovaries arise from this appearance of the ovaries though these are not cysts but ‘follicles arrested in growth’. Most women with PCOS have insulin resistance meaning that the body’s cells do not respond to insulin in abnormal manner.

Women with PCOS are also in the risk group of developing type 2 diabetes, which makes them more sensitive to insulin. This is why metformin is often used in the treatment of PCOS. Unfortunately,this medicine has an influence on the reduction in vitamin B12 levels after just a few months of intake and is accompanied by an increase in the concentration of homocysteine. Moreover, the inability to get pregnant and random stillbirth in women with PCOS may also be a consequence of the clinical deficiency of B12. In addition, in patients with hyperhomocysteinemia, stillbirth was observed more frequently than in women with correct homocysteine concentration. The researchers have a hypothesis those vitamins soluble in water that hasantioxidant properties and participate in metabolic transformations as regulators may be supplemented together with a reduction diet, thus being beneficial in the treatment of PCOS.

Biotin Helps to Reduce Insulin Resistance: Insulin resistance, inability to utilize insulin hormone is thought to be the main cause of PCOS. A properly balanced reduction diet withreduced GI improves the supply of vitamins in women with PCOS.Biotin (or vitamin B7) is one of the B vitamins.It is also an essential co-factor for a number of important metabolicreactions. For example, it helps the liver and pancreas to manage blood sugar level. Studies have also indicated that biotin or a group of vitamin B is supportive of nervous system health and it may promote healthy Blood fat metabolism.

Benefits of Biotin Supplements:
It is well known that large percentage of women who have polycystic ovarian syndrome also have (IGT) impaired Glucose tolerance. IGT is a pre-diabetic state of disturbed blood sugar that is associated with insulin resistance and increased risk of cardiovascular disease. In future it may also increase in developing higher risk Diabetes. Biotin appears to improve glucose tolerance in women suffering from PCOS. Women with PCOS frequently have unhealthy elevations of cholesterol or triglycerides. High doses of biotin reduce triglycerides as well as a “bad” form for cholesterol. The researchers concluded that pharmacological doses of biotin decrease hypertriglyceridemia. The triglyceride-lowering effect of biotin suggests that biotin could be used in the treatment of hypertriglyceridemia. Water-soluble vitamins do not require special proteins to aid absorption into the bloodstream and are able to move freely throughout the blood and body cells. Excess amounts are secreted in the urine, preventing a toxic build-up. Vitamin B like: Vitamins B2, B3, B5, and B6 are also very useful for controlling obesity in PCOS by the following ways:

• Vitamin B2: Processes fat, sugar, and protein into energy. It is also known as riboflavin.

• Vitamin B3: A component of the glucose tolerance factor which is released every time blood sugar rises, to help keep levels in balance. It is also known as niacin.
• Vitamin B5: This isessential for fat metabolism. It is also known as pantothenic acid.
• Vitamin B6: Maintains hormone balance. Balanced hormones are key to maintaining a healthy body weight.

Lastly, folate and vitamin B12 treatments are shown to improve insulin resistance in patients with metabolic syndrome. So, women with polycystic ovary syndrome should be aware of biotin (Vitamin B) supplements.