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A Long-Term Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris

Information source: Galderma
ClinicalTrials.gov processed this data on August 20, 2015
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: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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
Last updated: March 8, 2007

Page last updated: August 20, 2015

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