NCT01213199

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

March 23, 2015

Completed
Last Updated

February 18, 2021

Status Verified

March 1, 2015

Enrollment Period

1.1 years

First QC Date

September 30, 2010

Results QC Date

November 22, 2013

Last Update Submit

February 16, 2021

Conditions

Acne Scars

Outcome Measures

Primary Outcomes (1)

  • Global Scarring Severity

    Grade Level: 1. Macular disease 2. Mild disease 3. Moderate disease 4. Severe disease

    Week 24

Study Arms (1)

Differin 0.3%

EXPERIMENTAL

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

Interventions

AdapaleneDRUG

Adapalene Gel 0.3%

Also known as: Differin 0.3%
Differin 0.3%

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Subjects with active inflammatory acne lesions
  • Subjects with hypertrophic acne scars

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manisha PATEL

Baltimore, Maryland, 21231, United States

Location

Related Publications (1)

  • 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.

    PMID: 29549598DERIVED

Related Links

MeSH Terms

Interventions

Adapalene

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Results Point of Contact

Title
Fabien AUDIBERT, CPM
Organization
GALDERMA
fabien.audibert@galderma.com
+ 33 4 92 95 29 21

Study Officials

  • Manisha J. Patel, MD

    Johns Hopkins Medical Institut

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2010

First Posted

October 1, 2010

Study Start

March 1, 2011

Primary Completion

April 1, 2012

Study Completion

September 1, 2012

Last Updated

February 18, 2021

Results First Posted

March 23, 2015

Record last verified: 2015-03

Locations

US(1)