The efficacy and safety of adapalene gel 0.3% in the treatment of acne vulgaris: A randomized, multicenter, investigator-blinded, controlled comparison study versus adapalene gel 0.1% and vehicle

David M. Pariser, Diane M. Thiboutot, Scott D. Clark, Terry M. Jones, Yin Liu, Michael Graeber

Research output: Contribution to journalArticle

38 Citations (Scopus)

Abstract

A randomized, multicenter, investigator-blinded, active- and vehicle-controlled study was conducted to evaluate the efficacy and safety of adapalene gel 0.3% versus adapalene gel 0.1% and the corresponding gel vehicle. Subjects were assigned randomly to receive either adapalene gel 0.3%, adapalene gel 0.1%, or vehicle once daily for 12 weeks. A total of 214 subjects with moderate to moderately severe acne vulgaris were enrolled, and 85% of subjects completed the study. Adapalene gel 0.3% was significantly superior to adapalene gel 0.1% in total and noninflammatory lesion counts and in global severity score (P <. 05 for all). A concentration-dependent increase in clinical benefit for all efficacy assessments was observed. As expected, there were also statistically significant differences in all efficacy parameters in the adapalene gel 0.3% group relative to the vehicle group (P <. 001 for all). Treatment-related adverse events were mostly mild-to-moderate and similar between active groups. The results of this study show that adapalene gel 0.3% was superior to adapalene gel 0.1% and vehicle in the treatment of moderate to moderately severe acne while retaining a similar safety and tolerability profile to adapalene 0.1% gel.

Original languageEnglish (US)
Pages (from-to)145-151
Number of pages7
JournalCutis
Volume76
Issue number2
StatePublished - Aug 1 2005

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Acne Vulgaris
Gels
Research Personnel
Safety
Adapalene

All Science Journal Classification (ASJC) codes

  • Dermatology

Cite this

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abstract = "A randomized, multicenter, investigator-blinded, active- and vehicle-controlled study was conducted to evaluate the efficacy and safety of adapalene gel 0.3{\%} versus adapalene gel 0.1{\%} and the corresponding gel vehicle. Subjects were assigned randomly to receive either adapalene gel 0.3{\%}, adapalene gel 0.1{\%}, or vehicle once daily for 12 weeks. A total of 214 subjects with moderate to moderately severe acne vulgaris were enrolled, and 85{\%} of subjects completed the study. Adapalene gel 0.3{\%} was significantly superior to adapalene gel 0.1{\%} in total and noninflammatory lesion counts and in global severity score (P <. 05 for all). A concentration-dependent increase in clinical benefit for all efficacy assessments was observed. As expected, there were also statistically significant differences in all efficacy parameters in the adapalene gel 0.3{\%} group relative to the vehicle group (P <. 001 for all). Treatment-related adverse events were mostly mild-to-moderate and similar between active groups. The results of this study show that adapalene gel 0.3{\%} was superior to adapalene gel 0.1{\%} and vehicle in the treatment of moderate to moderately severe acne while retaining a similar safety and tolerability profile to adapalene 0.1{\%} gel.",
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The efficacy and safety of adapalene gel 0.3% in the treatment of acne vulgaris : A randomized, multicenter, investigator-blinded, controlled comparison study versus adapalene gel 0.1% and vehicle. / Pariser, David M.; Thiboutot, Diane M.; Clark, Scott D.; Jones, Terry M.; Liu, Yin; Graeber, Michael.

In: Cutis, Vol. 76, No. 2, 01.08.2005, p. 145-151.

Research output: Contribution to journalArticle

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