Abstract | OBJECTIVE: METHODS: Three hundred thirty-seven adolescent acne subjects (aged 12 to <18 years) with skin of color were evaluated from 2 multicenter, double-blind studies. Subjects were randomized to receive clindamycin phosphate 1.2%/BPO 2.5% gel or vehicle, once daily for 12 weeks. Efficacy and tolerability were evaluated. Data were compared with an adolescent (A) and skin of color (B) cohort from the same pivotal study enrolling 2,813 subjects. RESULTS: Superior mean percent reductions in inflammatory, noninflammatory, and total lesion counts were observed in subjects receiving clindamycin phosphate 1.2%/BPO 2.5% gel compared to vehicle. At week 12, clindamycin phosphate 1.2%/BPO 2.5% gel showed similar lesion reduction compared to groups A and B (P<0.001). Treatment success with clindamycin phosphate 1.2%/BPO 2.5% gel, assessed by investigator and subject, was superior to vehicle and comparable to that seen in groups A and B (P<0.001). Clindamycin phosphate 1.2%/ BPO 2.5% gel was associated with a low incidence of treatment-related AEs and a favorable cutaneous tolerability profile. CONCLUSIONS:
Clindamycin phosphate 1.2%/BPO 2.5% gel has been shown to be effective, safe, and well tolerated in moderate to severe acne in adolescents with skin of color.
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Authors | Lawrence F Eichenfield, Andrew C Krakowski |
Journal | Journal of drugs in dermatology : JDD
(J Drugs Dermatol)
Vol. 11
Issue 7
Pg. 818-24
(Jul 2012)
ISSN: 1545-9616 [Print] United States |
PMID | 22777222
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Anti-Bacterial Agents
- Dermatologic Agents
- Drug Combinations
- Gels
- clindamycin phosphate benzoyl peroxide combination
- Clindamycin
- Benzoyl Peroxide
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Topics |
- Acne Vulgaris
(drug therapy, pathology)
- Adolescent
- Anti-Bacterial Agents
(adverse effects, therapeutic use)
- Benzoyl Peroxide
(adverse effects, therapeutic use)
- Child
- Clindamycin
(adverse effects, therapeutic use)
- Dermatologic Agents
(adverse effects, therapeutic use)
- Double-Blind Method
- Drug Combinations
- Female
- Gels
- Humans
- Male
- Racial Groups
- Severity of Illness Index
- Skin Pigmentation
- Treatment Outcome
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