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Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT01213199
First received: September 30, 2010
Last updated: October 18, 2012
Last verified: October 2012
History of Changes
  Purpose

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:

MedlinePlus related topics: Acne Scars
Drug Information available for: Adapalene
U.S. FDA Resources

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%
  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01213199

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

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Galderma
ClinicalTrials.gov 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
Cicatrix
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Fibrosis
Pathologic Processes
Adapalene
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
 Analgesics
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

ClinicalTrials.gov processed this record on May 19, 2013