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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

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ClinicalTrials.gov Identifier: NCT00446043
Recruitment Status : Completed
First Posted : March 12, 2007
Last Update Posted : March 12, 2007
Information provided by:

Brief 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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Adapalene/Benzoyl Peroxide Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 452 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2004
Estimated Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00446043

United States, Oregon
Phoebe Rich, MD
Portland, Oregon, United States, 97210
Sponsors and Collaborators
Study Director: Michael Graeber, MD Galderma

Additional Information:
ClinicalTrials.gov Identifier: NCT00446043     History of Changes
Other Study ID Numbers: RD.06.SPR.18089
First Posted: March 12, 2007    Key Record Dates
Last Update Posted: March 12, 2007
Last Verified: March 2007

Keywords provided by Galderma:
Acne Vulgaris
Benzoyl Peroxide

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Benzoyl Peroxide
Adapalene, Benzoyl Peroxide Drug Combination
Dermatologic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents