Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars

This study has been completed.
Information provided by (Responsible Party):
Galderma Identifier:
First received: September 30, 2010
Last updated: October 18, 2012
Last verified: October 2012

The purpose of this study is to assess the efficacy and safety of Adapalene Gel 0.3% in the treatment of atrophic acne scars.

Condition Intervention Phase
Acne Scars
Drug: Adapalene
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars. A Pilot Study.

Resource links provided by NLM:

Further study details as provided by Galderma:

Primary Outcome Measures:
  • Global scarring severity [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

    Grade Level:

    1. Macular disease
    2. Mild disease
    3. Moderate disease
    4. Severe disease

Enrollment: 20
Study Start Date: March 2011
Study Completion Date: September 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Adapalene
    Adapalene Gel 0.3%

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female subjects of any race, aged 18 to 50 years inclusive
  • Subjects with a past history of acne and with moderate to severe facial atrophic acne scars

Exclusion Criteria:

  • Subjects with active inflammatory acne lesions
  • Subjects with hypertrophic acne scars
  Contacts and Locations
Please refer to this study by its identifier: NCT01213199

United States, Maryland
Manisha PATEL
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Principal Investigator: Manisha J. Patel, MD Johns Hopkins Medical Institut
  More Information

Additional Information:
No publications provided

Responsible Party: Galderma Identifier: NCT01213199     History of Changes
Other Study ID Numbers: RD.03.SPR.29088
Study First Received: September 30, 2010
Last Updated: October 18, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Pathologic Processes
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Central Nervous System Agents processed this record on April 16, 2014