Clinical trial NCT00422240: Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris
Official title: A Multi-Center, Randomized, Double-Blind, Parallel-Group Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel Compared With Adapalene Topical Gel, 0.1%; Benzoyl Peroxide Topical Gel, 2.5% and Topical Gel Vehicle in Subjects With Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Keywords: Acne vulgaris
Adapalene
Benzoyl Peroxide
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2007-01-15
Enrollment: 1668
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations were performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a participant should remain the same during the study.

The primary objective was to demonstrate the superiority in efficacy and assess safety of adapalene/benzoyl peroxide topical gel (adapalene/benzoyl peroxide gel) versus adapalene topical gel, 0.1% (adapalene monad); benzoyl peroxide topical gel, 2.5% (benzoyl peroxide monad) and topical gel vehicle (gel vehicle) in the treatment of acne vulgaris for up to 12 weeks.


Eligibility criteria: Inclusion Criteria:

* A clinical diagnosis of acne vulgaris with facial involvement.
* A minimum of 20 but not more than 50 inflammatory lesions
* A minimum of 30 but not more than 100 noninflammatory lesions
* A score of 3 (Moderate) on the Investigator's Global Assessment Scale

Primary outcomes:
measure: Percentage of Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward)
timeFrame: At Week 12
measure: Change in Inflammatory Lesion Count From Baseline to Week 12
timeFrame: Baseline to Week 12
measure: Change in Noninflammatory Lesion Count From Baseline to Week 12
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Percent Change From Baseline in Inflammatory Lesion Counts at Week 12
timeFrame: Baseline, Week 12
measure: Percent Change From Baseline in Noninflammatory Lesion Counts at Week 12
timeFrame: Baseline, Week 12
measure: Percent Change From Baseline in Total Lesion Counts at Week 12
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Miller MD
state: Texas
Study officials:
affiliation: Galderma R&D
name: Michael Graeber, MD
role: STUDY_DIRECTOR
References:
citation: Leyden JJ. A review of the use of combination therapies for the treatment of acne vulgaris. J Am Acad Dermatol. 2003 Sep;49(3 Suppl):S200-10. doi: 10.1067/s0190-9622(03)01154-x.
citation: Gold LS, Tan J, Cruz-Santana A, Papp K, Poulin Y, Schlessinger J, Gidner J, Liu Y, Graeber M; Adapalene-BPO Study Group. A North American study of adapalene-benzoyl peroxide combination gel in the treatment of acne. Cutis. 2009 Aug;84(2):110-6.