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
  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:


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
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: 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:
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:
Adapalene
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 October 22, 2014