Retinyl propionate and climbazole combination demonstrates clinical improvement to the appearance of hyperpigmentation and deep wrinkling with minimal irritation

• Published in: International journal of cosmetic science 2017-12, Vol.39 (6), p.589-599
• Main Authors: Hawkins, S., Adamus, J., Chiang, C.‐y., Covell, E., O'Leary, J., Lee, J.‐m.
• Format: Article
• Language: English
• Subjects: Adult; Aging; claim substantiation in vivo/in vitro; climbazole; Clinical trials; Double-Blind Method; Drug Therapy, Combination; Effectiveness; Female; Females; formulation skin care; Humans; Hyperpigmentation; Hyperpigmentation - drug therapy; Imidazoles - administration & dosage; Imidazoles - adverse effects; In vivo methods and tests; Instrumentation; Irritation; Male; Middle Aged; photoaging; Pigmentation; Propionic acid; Randomization; retinoid; Self-assessment; Skin; Skin Aging - drug effects; Vitamin A; Vitamin A - administration & dosage; Vitamin A - adverse effects; Vitamin A - analogs & derivatives; Young Adult
• ISSN: 0142-5463; 1468-2494
• DOI: 10.1111/ics.12412

Objective To evaluate a combination of retinyl propionate and climbazole (RPC) compared to 0.1% retinol for its efficacy, tolerance and ageing appearance. Method Forty‐five healthy Caucasian females, ages 40–70, with moderately photodamaged facial skin, were recruited for a 16‐week randomized, double‐blind, IRB‐approved facial study. The efficacy of RPC treatment was compared to 0.1% retinol, in the same product base formulation, with twice daily, split‐face product application. Changes in overall photodamage, fine lines and wrinkles, pigmentation and irritation were visually evaluated and measured by instrumentation. Subjective appraisal of efficacy was self‐assessed from images where subjects were blinded to treatment and time point. Irritancy potential was also evaluated in a 5‐day randomized, double‐blind, IRB‐approved patch study. Results Treatment with RPC resulted in significant (P < 0.05) improvement in ageing attributes compared to 0.1% retinol treatment, with minimal irritation. More than 50% of subjects showed improvement to deep wrinkles in the crow's feet area after 5 weeks of product application, and continued improvement to deep wrinkles was observed throughout the course of the study. Similarly, improvement was observed for the appearance of lines and wrinkles in the nasolabial fold (NLF) and for mottled hyperpigmentation. The results from subjective self‐assessment confirmed in vivo clinical assessments. In a separate patch study, significantly less irritation was observed with the RPC product as compared to the 0.1% retinol control product. Conclusion RPC delivered significant skin anti‐ageing benefits comparable or greater than 0.1% retinol, with minimal irritation. Résumé Objectif Évaluer une combinaison de rétinyle propionate et de climbazole (RPC) par rapport à 0,1% de rétinol pour son efficacité, sa tolérance et son rôle anti‐âge. Méthode Quarante‐cinq femmes de type Caucasienne, en bonne santé, âgées de 40 à 70 ans, avec la peau du visage modérément exposée au soleil, ont été recrutées pour une étude randomisée, en double aveugle, approuvée par l’IRB de 16 semaines. L'efficacité du traitement au RPC a été comparée à 0,1% de rétinol en utilisant la même formulation de base et grâce à une application de produit deux fois par jour en hémi‐visage. Les changements dus aux dommages photo‐induits, ridules et rides, pigmentation et irritation, ont été évalués visuellement et mesurés instrumentalement. L’évaluation subjective de l'efficacité