Journal of drugs in dermatology : JDD · 2025
Clindamycin Phosphate 1.2%/Adapalene 0.15%/ Benzoyl Peroxide 3.1% Gel for Moderate-to-Severe Acne: A Pooled Analysis by Age.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыНазвание и аннотация: Перевод в очереди
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Kircik Leon H, Harper Julie C, Baldwin Hilary, Eichenfield Lawrence F, Tanghetti Emil A, Graber Emmy, Woolery-Lloyd Heather C, Guenin Eric, Draelos Zoe D
Аннотация
BACKGROUND: Acne pathophysiology and presentation may differ between pediatric/adolescent/young adult (9-24 years) and adult (≥25 years) patients. Fixed-dose clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% (CAB) gel demonstrated superior efficacy to vehicle and component dyads with good safety/tolerability in 3 clinical trials of acne. This post hoc analysis evaluated the efficacy/safety of CAB in pediatric/adolescent/young adult ("younger") vs adult participants.
METHODS: In one phase 2 (NCT03170388) and two phase 3 (NCT04214652, NCT04214639) trials, participants aged greater than or equal to 9 years with moderate-to-severe acne were randomized to once-daily CAB or vehicle gel. Pooled data were analyzed for participants grouped by age: younger (9-24 years; n=515) and adult (greater than or equal to 25 years; n=142). Endpoints included the percentage of participants achieving treatment success (greater than or equal to 2-grade reduction from baseline in Evaluator's Global Severity Score and clear/almost clear skin) and least squares mean percent change from baseline in inflammatory/noninflammatory lesions at week 12. Treatment-emergent adverse events (TEAEs) were evaluated throughout.
RESULTS: At week 12, approximately half of CAB-treated participants in both age groups achieved treatment success (9-24: 50.6%; greater than or equal to 25: 49.0%) vs less than one-fourth with vehicle (15.7%; 20.6%; P<0.01, both). Across groups, CAB yielded >70% reductions in inflammatory/noninflammatory lesions vs 45% to 62% with vehicle (P≤0.001, all). For all endpoints, CAB efficacy was similar across age groups. Most TEAEs with CAB were of mild-to-moderate severity, and there were no age-related trends in safety/tolerability.
CONCLUSIONS: Fixed-dose, triple-combination CAB gel was efficacious and well tolerated in participants with moderate-to-severe acne, regardless of age. Approximately half of the participants achieved clear/almost clear skin, with >70% reductions in lesion counts.
METHODS: In one phase 2 (NCT03170388) and two phase 3 (NCT04214652, NCT04214639) trials, participants aged greater than or equal to 9 years with moderate-to-severe acne were randomized to once-daily CAB or vehicle gel. Pooled data were analyzed for participants grouped by age: younger (9-24 years; n=515) and adult (greater than or equal to 25 years; n=142). Endpoints included the percentage of participants achieving treatment success (greater than or equal to 2-grade reduction from baseline in Evaluator's Global Severity Score and clear/almost clear skin) and least squares mean percent change from baseline in inflammatory/noninflammatory lesions at week 12. Treatment-emergent adverse events (TEAEs) were evaluated throughout.
RESULTS: At week 12, approximately half of CAB-treated participants in both age groups achieved treatment success (9-24: 50.6%; greater than or equal to 25: 49.0%) vs less than one-fourth with vehicle (15.7%; 20.6%; P<0.01, both). Across groups, CAB yielded >70% reductions in inflammatory/noninflammatory lesions vs 45% to 62% with vehicle (P≤0.001, all). For all endpoints, CAB efficacy was similar across age groups. Most TEAEs with CAB were of mild-to-moderate severity, and there were no age-related trends in safety/tolerability.
CONCLUSIONS: Fixed-dose, triple-combination CAB gel was efficacious and well tolerated in participants with moderate-to-severe acne, regardless of age. Approximately half of the participants achieved clear/almost clear skin, with >70% reductions in lesion counts.