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Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars

Primary Purpose

Acne Scars

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Adapalene
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Scars

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Manisha PATEL

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Differin 0.3%

Arm Description

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.

Outcomes

Primary Outcome Measures

Global Scarring Severity
Grade Level: Macular disease Mild disease Moderate disease Severe disease

Secondary Outcome Measures

Full Information

First Posted
September 30, 2010
Last Updated
February 16, 2021
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT01213199
Brief Title
Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars
Official Title
Efficacy and Safety of Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars. A Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Scars

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Differin 0.3%
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Adapalene
Other Intervention Name(s)
Differin 0.3%
Intervention Description
Adapalene Gel 0.3%
Primary Outcome Measure Information:
Title
Global Scarring Severity
Description
Grade Level: Macular disease Mild disease Moderate disease Severe disease
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manisha J. Patel, MD
Organizational Affiliation
Johns Hopkins Medical Institut
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manisha PATEL
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29549598
Citation
Loss MJ, Leung S, Chien A, Kerrouche N, Fischer AH, Kang S. Adapalene 0.3% Gel Shows Efficacy for the Treatment of Atrophic Acne Scars. Dermatol Ther (Heidelb). 2018 Jun;8(2):245-257. doi: 10.1007/s13555-018-0231-8. Epub 2018 Mar 16.
Results Reference
derived
Links:
URL
http://galderma.com/
Description
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Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars

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