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...
Date First Received: March 8, 2007
Last Updated: March 8, 2007
Verified by: Galderma, March 2007
Clinical Trial Phase: Phase 3 | Start Date: February 2004
Overall Status: Completed
Estimated Enrollment: 452
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Adapalene/Benzoyl Peroxide
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 12 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: Galderma
Overall Clinical Trial Officials and Contacts
Michael Graeber, MD Study Director Galderma
Related Publications
References
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.
Additional Information
Information obtained from ClinicalTrials.gov on August 28, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00446043
Study ID Number: RD.06.SPR.18089
ClinicalTrials.gov Identifier: NCT00446043
Health Authority: United States: Food and Drug Administration
Clinical Trials Authorship and Review
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