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Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01213199
First Posted: October 1, 2010
Last Update Posted: March 23, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Galderma
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]

    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)
Arms Assigned Interventions
Experimental: Differin 0.3%

Differin® 0.3% Gel

Adapalene 0.3%

Topical to the face, once daily application in the evening for the first four weeks and twice daily application in the morning and in the evening for the following 20 weeks.

Drug: Adapalene
Adapalene Gel 0.3%
Other Name: Differin 0.3%

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
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): 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:
Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01213199     History of Changes
Other Study ID Numbers: RD.03.SPR.29088
First Submitted: September 30, 2010
First Posted: October 1, 2010
Results First Submitted: November 22, 2013
Results First Posted: March 23, 2015
Last Update Posted: March 23, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Adapalene
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents