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.

ACNE VULGARIS

Acne vulgaris (AV) is a globally occurring inflammatory skin disease manifesting in the pilosebaceous unit of human skin in the form of comedones, papules, and pustules that negatively affect self-esteem and work productivity. The etiopathogenesis of AV is complex, multifactorial, and not fully understood yet. The Cutibacterium acnes bacteria infestation, abnormal keratinization, and excessive lipid production are the main pillars of this disease. The higher colonization of C. acnes observed in inflammatory papules was believed, for decades, to be the main causative factor of AV. C. acnes, under normal aerobic conditions, act as a commensal to the skin, while oxygen deprivation triggers its virulency switching to a pathogenic behavior. C. acnestrapped inside anaerobic comedones environment release lipases with strong proinflammatory and chemoattractant activities that activate the local immune system resulting in inflammation.

Pilosebaceous unit governing cutaneous lipids level is called “the brain in the skin”due to its rich innervation among other skin appendages and its ability to synthetize by sebocytes and other follicular structures of a plethora of neuromediators. These neuromediators, both synthetized denovo and/or released from nerve fibres, regulate cutaneous steroidogenesis, androgen synthesis, and immune functions. The hyperproliferation and hyperactivity of sebocytes in the sebaceous gland during Acne Vulgaris result in excessive sebum production leading to comedones formation.

The nerve growth factor (NGF) plays crucial functions in human skin that are linked to tissue repair and regeneration by enabling reinnervation followed by accelerated cell migration and proliferation. The significantly higher expression of NGF was observed in inflammatory acne lesions, compared to healthy controls. It is proposed that NGF thus may be involved in impaired keratinocytes proliferation, neurogenic inflammation, and pain, all the hallmarks of acne. The cutaneous endocannabinoid system (ECS) regulates cell growth and differentiation, sebum production, and immune functions. The two main ECS representatives, anandamide (AEA) and 2-arachidonoylglycerol are produced by human sebocytes and modulate sebum production in receptor type-dependent fashion. Both ECS and Phytocannabinoids (plant-derived) have been shown to have a strong anti-acne activity that includes the normalization of impaired keratinocytes proliferation, attenuation of inflammatory responses, and homeostasis of SG lipogenesis.

Interestingly, cannabinoids reduce arachidonic acid-induced “acne-like” lipogenesis and facilitate the ‘beneficial’ triglycerides production with anti-inflammatory and microbiome-normalizing properties.

Acetylcholine (ACh) released from autonomic nerves or synthetized by skin cells acting via nicotinic receptor promote infundibular epithelial hyperplasia and follicular plugging leading to comedones formation during Acne Vulgaris.

**Source : (Cezary Skobowiat)**

THE ROLE OF NEUROMEDIATORS IN SKIN CONDITIONS

The skin is unique in many ways. It is the largest body organ, after the inclusion of the subcutaneous adipose tissue, protecting against environmental stressors, thus maintaining the entire body’s integrity and homeostasis. The skin quality may reflect the condition of other organs that are connected via the vast network of blood vessels and nerve fibers, e.g., skin-brain or skin-gut axes. The cutaneous neuroendocrine system along with the balanced microbiome plays a central role in maintaining regulatory functions. Neuromediators utilized by these systems act as cross-functional communicators, impacting skin functions and appearance. Finally, skin is perceived visually and tactile by us and analyzed instantly defining the way we perceive ourselves and others. Now it is becoming clear that skin functions and roles are far more complex and profound than thought before.

The current trends in modern cosmetic sciences focus on personalization that addresses an individual’s skin concerns in a causative manner. Thus, for example, targeting an off-tuned element (neuromediators) of the HPA axis, observed in prematurely aged skin, a phenomenon that is prevalent in flight attendants due to stress and impaired circadian rhythm, can be a great representation of neuromediators contribution toward personalization. The skin microbiome is another promising area where neuromediators can contribute to healthy-looking skin by facilitating the optimal conditions that foster microbiome diversity.

Therefore, there is an unmet need to provide a fair balance of information about the product, in particular, the featured technology, i.e. unique formulation | active ingredients. Consumers should have access to scientifically sound data delivered to them in a clear and easy-to-follow way. Ideally, a smooth translation of the featured technology (formulation /active ingredient) to the final benefit (claims) should be provided in a sequel of logical steps: WHAT -> WHY -> HOW -> BENEFIT.

For Example, New technology featured in a product (WHAT) inhibits melanin production with in vitro assays (WHY). As a result, the decreased melanin levels are measured in the skin, in vivo, with skin colourimeter or spectrophotometer (HOW). Finally, a lighter, more even skin complexion is captured with standardized photography (BENEFIT). In such a model, a smooth translation allows for claims substantiation in a logic-causative manner.

**Source : (Cezary Skobowiat)**

THE EFFECT OF pH ON SKIN

Maintenance of skin pH is essential to the health and normal functioning of the skin. Where there are elevations in the skin pH, there are unfavorable outcomes such as impairments of a permeability barrier homeostasis, decreased skin integrity, cohesion, and increased susceptibility to microbial infections. Alterations in these skin functionalities play a known role in the pathogenesis and clinical manifestations of skin disease.

Impaired Permeability Barrier Homeostasis

The pH of cutaneous epithelial cells, particularly within the SC, largely influences the physical, chemical, and microbial protection properties of the skin. Furthermore, an acidic pH is critical for permeability barrier homeostasis, in part because of two key lipid-processing enzymes: ß-glucocerebrosidase and acid sphingomyelinase. These proteins generate a family of ceramides from glucosylceramide and sphingomyelin precursors and exhibit low pH optima. Increased skin pH results in defective lipid processing and delayed maturation of lamellar membranes. These lipids from multi-lamellar sheets amidst the intracellular spaces of the SC are critical to the SC’s mechanical and cohesive properties. This enables the SC to function as an effective water barrier. Altered pH environments have been shown to affect not only lipid content but also lipid organization and intercellular lipid lamellae (ICLL) resulting in an impaired skin barrier. Impaired barrier function allows easier penetration of topically applied products and delays barrier recovery after injury or insult to the skin and can trigger the onset of inflammatory skin diseases.

Decreased Skin Integrity and Cohesion

Experimentation has shown that in a neutral pH environment, there is an enhanced tendency for the tape stripping to remove the SC, a demonstration of compromised skin integrity and cohesion. The reduced SC integrity and cohesion seen with alterations in pH may be partially related to a pH-dependent activation of the serine proteases that exhibit neutral pH optima. The literature supports that serine proteases are activated in environments of increased pH such as in inflammatory skin conditions, newborn and elderly individuals, and type I-II skin. Their activation leads to the premature degradation of corneodesmosomes, and hence increased desquamation, resulting in loss of integrity and cohesion.

Increased Susceptibility to Skin Infections

The acidic pH of the SC restricts colonization by pathogenic flora and encourages the persistence of normal microbial flora. Pertinently, newborn and elderly skin, intertriginous areas, and chronically inflamed skin display an increased skin pH and hence reduced resistance to pathogens. Higher pH (decreased acidity) and impaired buffering capacity predispose to infection and skin disease.

In Summary, increased skin pH can lead to abnormalities in the SC integrity/cohesion, permeability barrier homeostasis, pathogen resistance, and immune function. These abnormalities areattributable to the pH-mediated increase in the serine protease-mediated degradation of corneodesmosomes, defect in lipid processing, and decrease in antibacterial activity, respectively.

Now that we have a better understanding of the importance of maintaining tightly regulated skin pH, we can start to divulge the mechanisms behind skin acidification and buffering capacity.

**Healthy Skin Starts From Within**