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

Sponsor:	Galderma Laboratories, L.P.
Information provided by:	Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:	NCT00647556

Purpose

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.

Condition	Intervention	Phase
Skin Aging	Drug: adapalene gel, 0.3% Drug: tretinoin 0.05% emollient cream	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Comparative Study of Adapalene Gel, 0.3% Versus Tretinoin 0.05% Emollient Cream, for the Treatment of Photodamage

Resource links provided by NLM:

MedlinePlus related topics: Skin Aging

Drug Information available for: Adapalene Tretinoin

U.S. FDA Resources

Further study details as provided by Galderma Laboratories, L.P.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Enrollment:	30
Study Start Date:	April 2008
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
adapalene: Active Comparator adapalene	Drug: adapalene gel, 0.3% applied topically once daily in the evening
tretinoin: Active Comparator Tretinoin	Drug: tretinoin 0.05% emollient cream applied topically once daily in the evening

Detailed Description:

Same as above.

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00647556

Locations

United States, Michigan
University of Michigan Department of Dermatology
Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

Galderma Laboratories, L.P.

Investigators

Study Director:

Ronald W Gottschalk, MD

Galderma Laboratories, L.P.

More Information

No publications provided

Responsible Party:	Galderma Laboratories, L.P. ( Ronald W. Gottschalk, MD / Medical Director )
Study ID Numbers:	US10067
Study First Received:	March 26, 2008
Last Updated:	August 31, 2009
ClinicalTrials.gov Identifier:	NCT00647556 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antineoplastic Agents
Physiological Effects of Drugs
Adapalene
Pharmacologic Actions
Keratolytic Agents
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses

Tretinoin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Emollients

ClinicalTrials.gov processed this record on November 30, 2009