Efficacy and tolerability of combined topical treatment of acne vulgaris with adapalene and clindamycin: a multicenter, randomized, investigator-blinded study

doi:10.1067/S0190-9622(03)01152-6

Journal of the American Academy of Dermatology

Volume 49, Issue 3, Supplement, September 2003, Pages S211-S217

https://doi.org/10.1067/S0190-9622(03)01152-6 Get rights and content

Abstract

This multicenter, randomized, investigator-blinded study investigated the efficacy and tolerability of adapalene gel 0.1% plus clindamycin phosphate lotion 1%, compared with clindamycin plus vehicle for the treatment of mild to moderate acne vulgaris. A total of 249 patients applied clindamycin lotion twice daily and adapalene (125 patients) or vehicle gel (124 patients) once daily for 12 weeks. A significantly greater reduction of total (P < .001), inflammatory (P = .004) and noninflammatory lesions (P < .001) was seen in the clindamycin plus adapalene group than in the clindamycin plus vehicle group. These significant treatment effects were observed as early as week 4 for both noninflammatory and total lesion counts. Both treatment regimens were well tolerated. Although the worst scores for scaling (P < .05), dryness (P < .01), and stinging/burning (P < .05) were higher in the clindamycin plus adapalene group than in the clindamycin plus vehicle group in patients with moderate or severe irritation; in most cases these symptoms were of mild intensity.

Section snippets

Patients

Male and female patients with mild to moderate acne vulgaris were enrolled at 7 study centers. Patients were at least 12 years of age and had a global severity grade ranging from 2 to 8, according to the Leeds Revised Acne Grading System.21 They had 10 to 50 inflammatory facial lesions (no more than 3 nodules or cysts) and 20 to 150 noninflammatory facial lesions. Patients taking certain topical and systemic treatments were required to undergo specified washout periods before they could enter

Disposition of patients

A total of 249 patients took part in the study, 125 receiving clindamycin plus adapalene and 124 receiving clindamycin plus vehicle (Table I). This formed the ITT population. The PP population comprised 216 patients (86.7%), 33 being excluded due to inclusion violations, interfering medication missed doses, and compliance to the visit schedule. A total of 217 patients (87.1%) completed the study. Reasons for withdrawing from the study included adverse events (2 patients), patient’s request (11

Discussion

This study was designed to investigate whether the combination of clindamycin topical lotion 1% plus adapalene gel 0.1% provides a significantly greater and faster efficacy than clindamycin for the treatment of mild to moderate acne vulgaris. Results showed that the addition of adapalene gel 0.1% produced a faster and a clinically significant enhancement of the efficacy of clindamycin topical lotion 1% therapy for acne vulgaris. There were significantly greater reductions in total,

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This article is part of a supplement supported by an educational grant from Galderma International.

Funding source: Galderma International funded the research reported here.

¹: Disclosures: John Wolf has served as a consultant and Speaker Bureau member for Galderma. Michael Baker is a former employee and current consultant to Galderma R&D Inc. Two of the authors are employees of Galderma. The other authors have no conflict of interest to disclose.

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Efficacy and tolerability of combined topical treatment of acne vulgaris with adapalene and clindamycin: a multicenter, randomized, investigator-blinded study 1 ☆,

Abstract

Section snippets

Patients

Disposition of patients

Discussion

J Am Acad Dermatol

New treatments and therapeutic strategies for acne

Arch Fam Med

Systemic antibiotics for acne

Dermatology

An overview of topical antibiotics for acne treatment

Dermatology

A comparison of Cleocin-T solution, Cleocin-T gel and placebo in the treatment of acne vulgaris

Cutis

Efficacy and safety comparisons of adapalene (CD271) gel and tretinoin gel in the topical treatment of acne vulgaris. A European multicentre trial

J Dermatol Treat

Comparison of adapalene 0.1% solution and tretinoin 0.025% gel in the topical treatment of acne vulgaris

Br J Dermatol

Clindamycin phosphate used in combination with tretinoin in the treatment of acne

Int J Dermatol

Treatment of acne vulgaris with topically applied erythromycin and tretinoin

Acta Derm Venereol

Efficacy and tolerability of combined topical treatment of acne vulgaris with tretinoin and erythromycin in general practice

Drugs Exp Clin Res

Efficacy and tolerability of combined topical treatment of acne vulgaris with adapalene and clindamycin: a multicenter, randomized, investigator-blinded study ¹ ☆,