by Jayesh Chaudhary
While the U.S. demand for cosmeceuticals is projected to rise by 7.4 percent per year to $8.2 billion in 2012, many cosmeceutical products lack credible evidence, and thus, the industry is challenged to provide convincing evidence of the effectiveness of their products.
A mixture of cosmetics and pharmaceuticals, cosmeceuticals provide additional health-related benefits such as skin nourishing, improving skin tone, texture, radiance and reducing wrinkles. The skin care segment will account for 63 percent of all cosmeceutical product demand through 2012 and is expected to grow to $22.1 billion in worldwide sales by 2013. The healthy growth in the cosmeceutical market worldwide is attributed to the aging Baby Boomer generation, an increase in disposable income as well as aspirations of the younger generation to enjoy beautiful, young-looking skin while aging.
Challenges Faced by Cosmeceutical Manufacturers
Consumers are becoming aware about the science behind cosmeceutical products. They are becoming more erudite, demanding innovative products with exceptional quality. They are skeptical to use any product that does not provide clinical study efficacy or safety data. They prefer to use products from companies who are known to conduct clinical studies on finished formulations tested on human faces. Proof of efficacy of ingredients is more important because consumers have wide variety of choices and will discontinue use of ineffective products.
Comprehensive animal and human clinical evaluation studies to determine safety and efficacy is therefore a prerequisite for the development of cosmeceuticals. Ethical and statistically validated clinical studies give an opportunity for companies to substantiate their claims.
Assessing Safety and Efficacy
The comprehensive study design including purpose, clear identifiable end points, substantial sample size, appropriate statistical methods, and ensuring compliance to legal and ethical standards ensures authenticity of the product. The safety of the product can be established by simple tests such as: open or occluded patch tests; and complex tests such as repeat insult patch test, photo patch test or repeat insult photo patch test. Also ocular irritation study, phototoxicity study and routine microbiological testing of the final product are essential. The efficacy measures of clinical improvement should be expressed in terms of skin hydration, pigmentation, wrinkles, skin gloss, roughness, skin texture and tone, elasticity, etc. While designing cosmeceutical trials, one should have legal compliance with statutory norms that are country specific such as COLIPA for EU, USFDA, ASEAN directives, Bureau of Indian standards (BIS Act) and others.
Clinical Trials, India
India has bloomed as a hub for conducting clinical studies in South East Asia. The BioSpectrum-CMR Asia Pacific Clinical and Contract Research Organizations Survey 2011 depicted dermatology as one of the top five therapeutic areas of focus for CROs in Asia. Cosmeceutical companies outsource their clinical trials to CROs in India due to several advantages they offer.
Technology:
India’s state-of-the-art technology and infrastructure is at par with international standards. India is well equipped with sophisticated armamentarium such as mexameter/chromameter (to check skin color), corneometer (to measure skin hydration), sebumeter (to measure skin surface lipids), cutometer (to measure resiliency), derma spectrometer, sebufix, optical profilometry, fluorescent photography, ultrasound, laser doppler, colorimetry, etc. Dermatology centers have an excellent range of instruments from makers such as Courage + Khazaka (Gmbh), Konica Minolta, Optometrics LLC, Varian, Canon, etc.
Medical Expertise:
The Indian panels of dermatologists have extensive experience in skin therapy procedures like skin diode laser, pulsed dye laser, etc. Skin compatibility testing and monitoring adverse reactions is conducted only by technically qualified persons and under the supervision of a clinically competent medical doctor/physician.
ICH-GCP Compliance:
The trials in India are conducted in accordance with Good Clinical Practice and other required regulations to deliver quality and credible data. Several CROs in India have an added advantage of a vast experience in handling natural products, which makes India a center of choice for testing natural cosmetics.
Genetically Diverse Population:
The country has a huge genetically, culturally and socio-economically diverse population base and a vast pool of heterogeneous population. As tolerance, efficacy and safety parameters change with different skin types; products should ideally be tested on all the skin types as developed by Fitzpatrick, a recognized tool for dermatologic research. Thus, the diverse genetic population of India which covers Fitzpatrick skin type III to V allows wider testing sample for cosmeceuticals.
Time and Cost Effectiveness:
The enrollment rates in India are five to 10 times higher than the United States. Another distinct advantage is the low cost for product R&D. A joint study by the Federation of Indian Chamber of Commerce and Industry (FICCI) and Ernst and Young found that clinical trials cost in India is 50 to 60 percent less than in the developed markets.
The best way to ensure the credibility of a product is to conduct the proper testing that not only validates the product's claims, but gives consumers the science they need (and are looking for) in order to validate their purchase.
Jayesh Chaudhary is the CEO of Vedic Lifesciences, a full-service contract research organization (CRO) serving nutraceutical, cosmeceutical and traditional medicine industry. Vedic provides solutions to substantiate label claims and meet regulatory requirements.
References available on next page.
