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Trial record 40 of 82 for:    acne AND Acne Scars

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 : March 23, 2015
Sponsor:
Information provided by (Responsible Party):
Galderma

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acne Scars
Intervention Drug: Adapalene
Enrollment 20
Recruitment Details First patient in =25 March 2011, last patient out= 21 Sep 2012
Pre-assignment Details  
Arm/Group Title Differin® 0.3% Gel
Hide Arm/Group Description

Differin® 0.3% Gel Adapalene 0.3%

Topical to the face Once daily application in the evening for the first 4 weeks and twice daily application in the morning and in the evening for the following 20 weeks.

Period Title: Overall Study
Started 20
Completed 16
Not Completed 4
Arm/Group Title Differin® 0.3% Gel
Hide Arm/Group Description

Differin® 0.3% Gel Adapalene 0.3%

Topical to the face Once daily application in the evening for the first 4 weeks and twice daily application in the morning and in the evening for the following 20 weeks.

Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
Analysis population includes all 20 subjects enrolled into the study (Intent-to-Treat population).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
35.7  (8.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
9
  45.0%
Male
11
  55.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
1.Primary Outcome
Title Global Scarring Severity
Hide Description

Grade Level:

  1. Macular disease
  2. Mild disease
  3. Moderate disease
  4. Severe disease
Time Frame Week 24
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Hide Analysis Population Description
The analysis population includes 18 subjects whose data were available at this time frame (week 24).
Arm/Group Title Differin® 0.3% Gel
Hide Arm/Group Description:

Differin® 0.3% Gel Adapalene 0.3%

Topical to the face Once daily application in the evening for the first 4 weeks and twice daily application in the morning and in the evening for the following 20 weeks.

Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.7  (0.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Differin® 0.3% Gel
Hide Arm/Group Description

Differin® 0.3% Gel Adapalene 0.3%

Topical to the face Once daily application in the evening for the first 4 weeks and twice daily application in the morning and in the evening for the following 20 weeks.

All-Cause Mortality
Differin® 0.3% Gel
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Differin® 0.3% Gel
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Differin® 0.3% Gel
Affected / at Risk (%)
Total   0/20 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Fabien AUDIBERT, CPM
Organization: GALDERMA
Phone: + 33 4 92 95 29 21
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