Vincenzo Nobile
The main regulatory frameworks governing the cosmetic industry dates back to 1938 in the United States (US) and 40 years later in Europe (EU). Since then, both the US and EU cosmetic legislations have inspired the regulatory framework of a number of countries working toward harmonisation of cosmetics legislation. During the years the requirements for the efficacy of cosmetic products have been implemented to adapt them to the state of the art; however no clear guidelines for efficacy testing on cosmetic products exist. The lack of guidelines and/or shared position on cosmetic testing represents the missing link between the regulatory requirements and the consumer protection from misleading claims in the real life. On the other side a regulatory claimed prerequisite is ineffective if clear and specific testing methodologies are not available to the cosmetic industry. This introduce a discretionary element decreasing the strength of the original regulatory requirement, having an impact on consumer protection from misleading claims, and sometimes decreasing the credibility of the cosmetic product in the marketplace. Initiatives aimed at developing clear, specific for cosmetic products, and effective guidelines should arrive from the academy, industry, and professional associations. This manuscript is aimed to give an overview of the main ethical, technical and regulatory concerns affecting the design of an efficacy study carried out on humans.
Sidharth Sonthalia
Patterned hair loss (PHL) is one of the most commonly encountered problems for dermatologists. PHL at an early age is often cosmetically unacceptable, tends to be persistent and inflicts a profound negative impact on one’s quality of life. Androgenetic alopecia (AGA) affects both genders in a distinctive pattern of hair loss from the scalp (MPHL for male PHL and FPHL or female PHL). The etiopathogenesis of AGA is complex, so far the major factor emphasized to be involved has been the undesirable androgen metabolism at the hair follicle level. In this review article, we shall dwell upon the relatively newly understood pathophysiological factors behind the genesis of AGA apart from the hormonal factors like the Wnt/β-catenin pathway, follicular micro-inflammation, prostaglandin imbalance, loss of extracellular matrix and oxidative stress. Based on the sound understanding of these factors we will be elaborating upon therapies for treatment of AGA beyong minoxidil, finasteride and hair transplantation. Amongst the therapeutic options discussed include topical 5alpha reductase (AR) inhibitors like finasteride, oral 5AR inhibitor – dual receptor antagonist dutasteride, botanical 5AR inhibitors, oral anti-androgens and estrogens for FPHL like spiranolactone, drospirenone etc. Wnt/β-catenin activators like topical valproic acid, hair stem cell based therapies, prostaglandin based therapies, tetrapeptides, nutritional and anti-oxidants and many more.