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Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars

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.
 
ClinicalTrials.gov Identifier: NCT01213199
Recruitment Status : Completed
First Posted : October 1, 2010
Results First Posted : March 23, 2015
Last Update Posted : February 18, 2021
Sponsor:
Information provided by (Responsible Party):
Galderma R&D

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Acne Scars Drug: Adapalene Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: N/A
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.
Study Start Date : March 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Scars
Drug Information available for: Adapalene

Arms and Interventions
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Arm Intervention/treatment
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%


Outcome Measures
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Primary Outcome Measures :
  1. Global Scarring Severity [ Time Frame: Week 24 ]

    Grade Level:

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


Eligibility Criteria
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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
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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
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United States, Maryland
Manisha PATEL
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
Galderma R&D
Investigators
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Principal Investigator: Manisha J. Patel, MD Johns Hopkins Medical Institut
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT01213199    
Other Study ID Numbers: RD.03.SPR.29088
First Posted: October 1, 2010    Key Record Dates
Results First Posted: March 23, 2015
Last Update Posted: February 18, 2021
Last Verified: March 2015
Additional relevant MeSH terms:
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Acne Vulgaris
Atrophy
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Pathological Conditions, Anatomical
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