A Long-Term Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris
Information source: Galderma
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acne Vulgaris
Intervention: Adapalene/Benzoyl Peroxide (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Galderma Official(s) and/or principal investigator(s):
Michael Graeber, MD, Study Director, Affiliation: Galderma
Summary
This is a multi-centre, open-label, non-comparative study to evaluate the long-term safety
and efficacy profile of Adapalene/Benzoyl Peroxide Gel.
Subjects are evaluated at Baseline, Weeks 1 and 2, and Months 1, 2, 4, 6, 8, 10, and 12.
Safety is evaluated by spontaneous reports of Adverse Events (AEs), the Local Tolerability
Assessment (Erythema, Scaling, Dryness, and Stinging/Burning), routine laboratory testing
(haematology, blood chemistry, and urinalysis), and monitoring of suspected sensitizations.
Efficacy is evaluated by analysis of Percent Change from Baseline in Inflammatory,
Noninflammatory, and Total Lesion Counts, and by the Subject’s Assessment of Acne.
Clinical Details
Official title: A Long-Term Safety and Efficacy Study of a Fixed Combination of Adapalene 0.1% and Benzoyl Peroxide 2.5% (Adapalene and Benzoyl Peroxide Topical Gel) Gel in Subjects With Acne Vulgaris
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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
Exclusion Criteria:
- Subjects with presence of nodules or cysts.
- Acne conglobata, acne fulminans, secondary acne, or severe acne.
- 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
Locations and Contacts
Phoebe Rich, MD, Portland, Oregon 97210, United States
Additional Information
Related publications: 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. Review.
Starting date: February 2004
Ending date: May 2004
Last updated: March 8, 2007
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