BACKGROUND: Facial acne is common in adolescents and can have a significant psychosocial impact. Treatments prescribed should not add stress by causing excessive localized irritation. OBJECTIVE: To determine whether the lowest concentration of tretinoin microsphere gel (TMG) currently available (0.04%) provides an acceptable balance of efficacy and tolerability for adolescents with moderate facial acne. METHODS: The findings of 2 multicenter, randomized, double-blind, vehicle-controlled trials of TMG 0.04% applied once nightly for 12 weeks in 245 adolescents ages 11 to 16 years with moderate facial acne were combined. Patients were evaluated via changes in acne lesion counts and the occurrence of cutaneous and other adverse effects. RESULTS:Tretinoin microsphere gel 0.04% reduced total, noninflammatory, and inflammatory lesion counts to a significantly greater extent than the vehicle gel at 12 weeks (P<.000005). The mean percentage reductions in noninflammatory and inflammatory lesion counts at 12 weeks in females were 45.0% and 51.4%, respectively; and in males, 20.5% and 36.7%, respectively. Tretinoin microsphere gel 0.04% was tolerated well, with over 70% of patients experiencing no cutaneous adverse events (AEs). CONCLUSION:Tretinoin microsphere gel 0.04% is effective in significantly reducing all types of acne lesions in adolescents with moderate facial acne ages 11 to 16 years, and has a low incidence of cutaneous AEs.
RCT Entities:
BACKGROUND:Facial acne is common in adolescents and can have a significant psychosocial impact. Treatments prescribed should not add stress by causing excessive localized irritation. OBJECTIVE: To determine whether the lowest concentration of tretinoin microsphere gel (TMG) currently available (0.04%) provides an acceptable balance of efficacy and tolerability for adolescents with moderate facial acne. METHODS: The findings of 2 multicenter, randomized, double-blind, vehicle-controlled trials of TMG 0.04% applied once nightly for 12 weeks in 245 adolescents ages 11 to 16 years with moderate facial acne were combined. Patients were evaluated via changes in acne lesion counts and the occurrence of cutaneous and other adverse effects. RESULTS:Tretinoin microsphere gel 0.04% reduced total, noninflammatory, and inflammatory lesion counts to a significantly greater extent than the vehicle gel at 12 weeks (P<.000005). The mean percentage reductions in noninflammatory and inflammatory lesion counts at 12 weeks in females were 45.0% and 51.4%, respectively; and in males, 20.5% and 36.7%, respectively. Tretinoin microsphere gel 0.04% was tolerated well, with over 70% of patients experiencing no cutaneous adverse events (AEs). CONCLUSION:Tretinoin microsphere gel 0.04% is effective in significantly reducing all types of acne lesions in adolescents with moderate facial acne ages 11 to 16 years, and has a low incidence of cutaneous AEs.