Adapalene Gel 0.3% Versus Tretinoin Cream 0.05% for Treatment of Photodamage - Tabular View

Tracking Information

First Received Date ^ICMJE

March 26, 2008

Last Updated Date

August 31, 2009

Start Date ^ICMJE

April 2008

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Efficacy - Overall Integrated Assessment of Photodamage at week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00647556 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Efficacy - Photonumeric Scale for the Assessment of Photodamage, Overall Integrated Assessment of Photodamage, Investigator Evaluation of Global Response (Improvement), Subject Evaluation of Improvement at week 12 & 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Adapalene Gel 0.3% Versus Tretinoin Cream 0.05% for Treatment of Photodamage

Official Title ^ICMJE

A Comparative Study of Adapalene Gel, 0.3% Versus Tretinoin 0.05% Emollient Cream, for the Treatment of Photodamage

Brief Summary

The primary purpose of this study is to compare the efficacy of adapalene (Differin®) gel 0.3% and tretinoin 0.05% emollient cream for the treatment of signs of photodamage, with tolerability assessment as a secondary objective.

Detailed Description

Same as above.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Skin Aging

Intervention ^ICMJE

Drug: adapalene gel, 0.3%
Drug: tretinoin 0.05% emollient cream

Study Arms / Comparison Groups

Active Comparator: adapalene
Active Comparator: Tretinoin

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

February 2010

Estimated Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Male or Female aged 40 years of age and older with Fitzpatrick skin types I through III
Clinically moderate to severe photodamage

Exclusion Criteria:

Subjects with history of laser resurfacing, dermabrasion, medium or deep chemical peel of the face
Subjects with diagnosis of skin cancer within 3 months of study entry
Subjects who have had superficial chemical peels, exfoliation or microdermabrasion of the face within 3 months of study entry
Subjects who have had botulinum toxin for facial rejuvenation within 6 months of study entry and are unwilling to refrain from botulinum toxin treatments during the study

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00647556

Responsible Party

Ronald W. Gottschalk, MD / Medical Director, Galderma Laboratories, L.P.

Study ID Numbers ^ICMJE

US10067

Study Sponsor ^ICMJE

Galderma Laboratories, L.P.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Ronald W Gottschalk, MD

Galderma Laboratories, L.P.

Information Provided By

Galderma Laboratories, L.P.

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP