A novel gel formulation combining tretinoin 0.04% and clindamycin 1% using a controlled release microsphere delivery system effectively treats acne vulgaris without the skin irritation associated with topical tretinoin alone, according to results from a phase 3 trial published February 5 in the Journal of Dermatological Treatment.
Topical tretinoin is a proven acne treatment, but many patients have difficulty tolerating treatment-related skin irritation and sun sensitivity. Researchers studied use of a topical formulation with tretinoin microsphere (0.04%) and clindamycin (1%), comparing it to one of two monotherapies, tretinoin 0.025% or clindamycin 1%, in a study of 750 acne vulgaris patients.
“Tretinoin gel microsphere (0.04%) is a novel formulation developed to minimize tretinoin-associated cutaneous irritation while maintaining the efficacy. in this novel formulation, tretinoin is entrapped in porous polymeric microspheres that serve as a reservoir and deliver the drug in a controlled manner of a longer period, and thus, reducing irritation,” according to the authors.
The microsphere formulation also helps protect against tretinoin-related photo degradation, they write.
Researchers in India studied patients ages 12 years and older who had been diagnosed with facial acne. In the multicenter study, patients were randomized to receive one of the three therapies, applying it once daily for 12 weeks. All patients had an investigator’s Static Global Assessment (ISGA) score of 3 (moderate) or 4 (severe) at the study’s start.
Dr. Reddy’s Laboratories funded the study and company employees were among the authors.
Dogra S, Sumathy TK, Nayak C, et al. Efficacy and safety comparison of combination of 0.04% tretinoin microspheres plus 1% clindamycin versus their monotherapy in patients with acne vulgaris: a phase 3, randomized, double-blind study. J Dermatolog Treat. 2020;:1-9.