A twelve week clinical study testing efficacy and safety of a cosmetic cream with novel actives for uneven skin tone, hyperpigmentation & photoaging

Title : A twelve week clinical study testing efficacy and safety of a cosmetic cream with novel actives for uneven skin tone, hyperpigmentation & photoaging

Abstract:

Uneven skin tone-hyperpigmentation is a common pigmentary disorder affecting all ages. This uneven skin tone damage from sun exposure, (solar lentigos/age spots/sunspots) or skin disruption following acne, or rashes (post inflammatory hyperpigmentation -PIH) or hormonal changes (melasma) can lead to significant psychosocial impairment. Dyschromia is a result of various alterations in biochemical processes regulating melanogenesis. Treatments include daily use of sunscreen with lightening, brightening and exfoliating products.  Depigmentation is achieved by various agents including hydroquinone, arbutin, azelaic acid, aloesin, mulberry, licorice extracts, kojic acid, niacinamide, retinol, resorcinol, ellagic acid, green tea, turmeric, soy, ascorbic acid, and tranexamic acid which interfere with mechanisms of melanin synthesis. While various cosmetics countering these conditions are available, lack of efficacy, tolerability, and length of time to see effects are issues that exist. Yearning for an efficacious product intervention is at an all-time high. Products with multiple ingredients are available and more being formulated exploiting strength/s of each individual ingredient, in the hope of obtaining higher efficacy, tolerability and showing effects in less time. While immediate correction is much sought after, patience and diligence are key.

Our objective was to assess the effects of facial product with pigmentation treatment and UV protection for 12 Weeks in 35 healthy F (35-65y) meeting study criteria.  Subjects with mild to moderate hyperpigmentation and fine lines with no use of skin lightening products in last six months or any dermatological procedures in last twelve months before study start were included. Efficacy parameters included expert visual grading for hyperpigmentation, radiance, skin tone & smoothness, fine lines, and wrinkles bioinstrumentation (Corneometer®, Colorimeter®, Mexameter®) digital imaging (Visia-CR®), and self-assessment questionnaires. Safety included grading for erythema, edema, and self-assessments for itching, stinging, tingling, and burning.  

Our results showed statistically significant improvement in various parameters -clinical grading scores, bioinstrumentation and digital photos for hyperpigmentation-brown spots, fine lines/wrinkles, skin tone, radiance, skin smoothness and overall appearance compared to baseline. The product was well-tolerated and liked by subjects.

Conclusion: Facial skin tone -hyperpigmentation are of great concern. Efficacious and safe treatment strategies are being increasingly sought after. Well-thought-out clinical trials with appropriate study designs to distinguish evidence-based products are a pressing priority.  While the multifunctional cosmetic product tested in our clinical study showed a level of efficacy, tolerability, and subject satisfaction in dealing with uneven skin tone-hyperpigmentation and overall photoaging, Future studies for longer duration are much needed.

Biography:

Dr Nalini Kaul completed her Master of Science in Biochemistry from Kashmir University in India and her PhD. from the reputed PGIME&R Chandigarh, India. She got her post-doctoral training at St Boniface General Hospital Winnipeg Canada and at the University of Southern California, USA. Thereafter she took a Senior Scientist position at the University of Dallas, Texas. Following her return to Canada in 2000 she worked as Technical Director on Clinical trials with Hill Top Research and then, moved on to hold a joint appointment as Sr. Director of Regulatory Affairs and Director of Clinical Trials with Source Nutraceutical Inc. At present she is Vice President of Technical services at Princeton Consumer Research, a CRO conducting clinical trials serving North American and the UK. She serves as technical expert, advising and consulting with clients. She has been an Investigator on many trials related to skin, antiaging, hair care, dandruff, photobiology, dietary supplements, probiotics, the microbiome and more. She has published 40 papers in national and international journals, has several book chapters, magazine articles, other writeups to her credit and has presented widely at conferences, both nationally and internationally. Research experience involves: Cosmetics, Natural Health Products/ dietary supplements, Veterinary products, and OTC drugs. She regularly consults on efficacy and safety studies involving Antiaging; hydration, barrier disruption, antidandruff, patch testing, sunscreen use antiperspirants/deodorants, supplements, devices and use tests.