Adapalene Gel 0.3% in the Treatment of Atrophic Acne Scars

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01213199
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Duration (Months): 18.1
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acne Scars	Drug: Adapalene	Phase 2

Study Design

• Study Type: Interventional
• 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: Mar 1, 2011
• Actual Primary Completion Date: Apr 1, 2012
• Actual Study Completion Date: Sep 1, 2012

Arms and Interventions

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 Names: Differin 0.3%

Outcome Measures

Primary Outcome Measures

1. Global Scarring Severity [Week 24]

   Grade Level: Macular disease Mild disease Moderate disease Severe disease

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Manisha PATEL	Baltimore	Maryland	United States	21231

Sponsors and Collaborators

• Galderma R&D

Investigators

• Principal Investigator: Manisha J. Patel, MD, Johns Hopkins Medical Institut

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT01213199
• Other Study ID Numbers: RD.03.SPR.29088
• First Posted: Oct 1, 2010
• Last Update Posted: Feb 18, 2021
• Last Verified: Mar 1, 2015

• Additional relevant MeSH terms: Acne Vulgaris; Atrophy; Adapalene

Study Results

Participant Flow

Recruitment Details	First patient in =25 March 2011, last patient out= 21 Sep 2012

Arm/Group Title	Differin® 0.3% Gel
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

Baseline Characteristics

Arm/Group Title	Differin® 0.3% Gel
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 Participants	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.7 (8.71)
Sex: Female, Male (Count of Participants)
Female	9 45%
Male	11 55%
Region of Enrollment (participants) [Number]
United States	20 100%

Outcome Measures

1. Primary Outcome

Title	Global Scarring Severity
Description	Grade Level: Macular disease Mild disease Moderate disease Severe disease
Time Frame	Week 24

Outcome Measure Data

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
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.
Measure Participants	18
Mean (Standard Deviation) [units on a scale]	2.7 (0.8)

Adverse Events

Arm/Group Title	Differin® 0.3% Gel
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Differin® 0.3% Gel
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Differin® 0.3% Gel
	Affected / at Risk (%)	# Events
Total	0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.