Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars
This study has been completed.
Information provided by (Responsible Party):
First received: September 30, 2010
Last updated: March 9, 2015
Last verified: March 2015
The purpose of this study is to assess the efficacy and safety of Adapalene Gel 0.3% in the treatment of atrophic acne scars.
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Efficacy and Safety of Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars. A Pilot Study.
Primary Outcome Measures:
- Global Scarring Severity [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
- Macular disease
- Mild disease
- Moderate disease
- Severe disease
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2012 (Final data collection date for primary outcome measure)
Experimental: Differin 0.3%
Differin® 0.3% Gel
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.
Adapalene Gel 0.3%
Other Name: Differin 0.3%
|Ages Eligible for Study:
||18 Years to 50 Years (Adult)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- Subjects with active inflammatory acne lesions
- Subjects with hypertrophic acne scars
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
|Baltimore, Maryland, United States, 21231 |
||Manisha J. Patel, MD
||Johns Hopkins Medical Institut
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 30, 2010
|Results First Received:
||November 22, 2013
||March 9, 2015
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 02, 2016
Anti-Inflammatory Agents, Non-Steroidal
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs