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Shilpi Dhawan

Shilpi Dhawan

Dr Reddy’s Laboratories
India

Title: Efficacy and Safety of Tretinoin (Microsphere) 0.04% and Clindamycin 1% Combination Gel in Comparison to Tretinoin 0.025% Gel and Clindamycin 1% Gel in the treatment of Moderate to Severe Acne Vulgaris.

Biography

Biography: Shilpi Dhawan

Abstract

Statement of the Problem: Topical retinoids such as Tretinoin are currently used as monotherapy and also in combination with clindamycin for treatment of acne.  Although the effectiveness of topical tretinoin is well established, yet the associated skin irritation is a limiting factor in some subjects due to the availability of drug to skin in high concentration in a short period. Novel tretinoin formulation incorporating microsphere technology may improve treatment tolerability, encourage adherence, and contribute to better long-term therapeutic outcomes. 

Purpose  was to evaluate efficacy, safety and tolerability of novel formulation of Tretinoin (Microsphere) 0.04% and Clindamycin 1% combination gel (T+C) versus Tretinoin 0.025% (T) and Clindamycin 1% (C) in the treatment of Acne vulgaris.

Methodology & Theoretical Orientation: Eligible male and female subjects ≥ 12 years in age with clinical diagnosis of moderate to severe facial acne vulgaris and willing to provide informed consent were randomized in 2:2:1 ratio [Tretinoin (microsphere) 0.04% and Clindamycin 1% combination gel(T+C): Tretinoin 0.025%(T): Clindamycin 1%(C)] and instructed to apply a pea-sized amount of the products to the entire face once daily at bedtime for 12 weeks. Efficacy was evaluated by assessing the reduction in count and severity of acne lesions at each visit. Local tolerability assessments were done at all follow-up visits.

 Findings: In our study, a statistically significant reduction in acne lesion count was observed with T+C compared to both T and C showing superior efficacy with combination. An early and a higher response rate in efficacy was observed in T+C arm compared to T and C arms. The combination was well tolerated in the study.

Conclusion & Significance:  The combination therapy of Tretinoin with microsphere technology and Clindamycin improved patient satisfaction and adherence to treatment by providing superior efficacy and faster onset of action with better tolerability