Status:
COMPLETED
A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris
Lead Sponsor:
Galderma R&D
Conditions:
Acne Vulgaris
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety only), Baseli...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- More than one acne nodule or any acne cyst.
- Acne conglobata, acne fulminans, secondary acne, or severe acne.
- Known previous participation in an Adapalene/Benzoyl Peroxide Topical Gel Trial.
- Underlying diseases that require the use of interfering topical or systemic therapy.
- Use of prohibited medications prior to the study unless appropriate washout period is documented
- Use of hormonal contraceptives solely for control of acne
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
1670 Patients enrolled
Trial Details
Trial ID
NCT00421993
Start Date
October 1 2006
End Date
December 1 2007
Last Update
February 18 2021
Active Locations (62)
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1
Medical Affliated Research Center
Huntsville, Alabama, United States, 35801
2
Dermatology Research of Arkansas
Little Rock, Arkansas, United States, 72205
3
Associates in research, Inc.
Fresno, California, United States, 93720
4
University of California, Irvine
Irvine, California, United States, 92697-1385