Sharleen St Surin-Lord1,2,3, Todd E Schlesinger1,2,3, Eric Guenin1,2,3. 1. Dr. St. Surin-Lord is with Visage Dermatology and Aesthetics Center in Largo, Maryland. 2. Dr. Schlesinger is with the Clinical Research Center of the Carolinas in Charleston, South Carolina. 3. Dr. Guenin is with Ortho Dermatologics in Bridgewater, New Jersey.
Abstract
Background: The efficacy of tretinoin is well documented in adolescent acne, with limited data available in preadolescents. A novel tretinoin 0.05% lotion formulation has been shown to be effective and well tolerated in moderate-to-severe acne. Objective: We sought to evaluate the safety and efficacy of tretinoin 0.05% lotion in preadolescent (≤13 years) and adolescent (14-17 years) subjects with acne. Methods: This study involved the post-hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled Phase III studies. Preadolescent (n=154) and adolescent (n=575) subjects were randomized (1:1) to tretinoin 0.05% lotion or vehicle used once daily for 12 weeks. Efficacy assessments included lesion count reductions, treatment success (at least a two-grade reduction in the Evaluator's Global Severity Score and clear/almost clear). Safety, adverse events (AEs), and cutaneous tolerability were evaluated. Results: At Week 12, mean percent reductions in inflammatory and noninflammatory lesion counts were 49.5% and 44.0% in preadolescents and 50.5% and 41.2% in adolescents, compared to 31.4%, 18.8%, 35.9%, and 23.8% for the vehicle, respectively (all p≤0.001). Treatment success was achieved by 23.7% (preadolescent) and 17.5% (adolescent) of subjects by Week 12, compared to 7.2% (p=0.009) and 8.8% (P=0.004) with the vehicle. The majority of AEs were mild and transient; the most frequent occurrences were application site pain and dryness in 5.6% and 2.8% of preadolescents and 3.2% and 3.6% of adolescents. Local cutaneous safety and tolerability assessments were generally mild-to-moderate, with slight transient increases in mean scores at Week 4. Conclusions: Tretinoin 0.05% lotion was significantly more effective than the vehicle in achieving treatment success and reducing inflammatory and noninflammatory lesions in preadolescent and adolescent acne. It was well tolerated, and all treatment-related AEs were mild or moderate.
RCT Entities:
Background: The efficacy of tretinoin is well documented in adolescent acne, with limited data available in preadolescents. A novel tretinoin 0.05% lotion formulation has been shown to be effective and well tolerated in moderate-to-severe acne. Objective: We sought to evaluate the safety and efficacy of tretinoin 0.05% lotion in preadolescent (≤13 years) and adolescent (14-17 years) subjects with acne. Methods: This study involved the post-hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled Phase III studies. Preadolescent (n=154) and adolescent (n=575) subjects were randomized (1:1) to tretinoin 0.05% lotion or vehicle used once daily for 12 weeks. Efficacy assessments included lesion count reductions, treatment success (at least a two-grade reduction in the Evaluator's Global Severity Score and clear/almost clear). Safety, adverse events (AEs), and cutaneous tolerability were evaluated. Results: At Week 12, mean percent reductions in inflammatory and noninflammatory lesion counts were 49.5% and 44.0% in preadolescents and 50.5% and 41.2% in adolescents, compared to 31.4%, 18.8%, 35.9%, and 23.8% for the vehicle, respectively (all p≤0.001). Treatment success was achieved by 23.7% (preadolescent) and 17.5% (adolescent) of subjects by Week 12, compared to 7.2% (p=0.009) and 8.8% (P=0.004) with the vehicle. The majority of AEs were mild and transient; the most frequent occurrences were application site pain and dryness in 5.6% and 2.8% of preadolescents and 3.2% and 3.6% of adolescents. Local cutaneous safety and tolerability assessments were generally mild-to-moderate, with slight transient increases in mean scores at Week 4. Conclusions: Tretinoin 0.05% lotion was significantly more effective than the vehicle in achieving treatment success and reducing inflammatory and noninflammatory lesions in preadolescent and adolescent acne. It was well tolerated, and all treatment-related AEs were mild or moderate.
Authors: A E Koku Aksu; S Metintas; Z N Saracoglu; G Gurel; I Sabuncu; I Arikan; C Kalyoncu Journal: J Eur Acad Dermatol Venereol Date: 2011-11-10 Impact factor: 6.166
Authors: Stephen K Tyring; Leon H Kircik; David M Pariser; Eric Guenin; Varsha Bhatt; Radhakrishnan Pillai Journal: J Drugs Dermatol Date: 2018-10-01 Impact factor: 2.114