Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Galderma
ClinicalTrials.gov Identifier:
NCT00446043
First received: March 8, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  Purpose

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 Intervention Phase
Acne Vulgaris
Drug: Adapalene/Benzoyl Peroxide
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Galderma:

Estimated Enrollment: 452
Study Start Date: February 2004
Estimated Study Completion Date: May 2004
  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446043

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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00446043     History of Changes
Other Study ID Numbers: RD.06.SPR.18089
Study First Received: March 8, 2007
Last Updated: March 8, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Galderma:
Acne Vulgaris
Adapalene
Benzoyl Peroxide

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Facial Dermatoses
Sebaceous Gland Diseases
Skin Diseases
Adapalene
Benzoyl Peroxide
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014