Adapalene Gel 0.3% Versus Tretinoin Cream 0.05% for Treatment of Photodamage
Information source: Galderma Laboratories, L.P.
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Skin Aging
Intervention: adapalene gel, 0.3% (Drug); tretinoin 0.05% emollient cream (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Galderma Laboratories, L.P. Official(s) and/or principal investigator(s):
Ronald W Gottschalk, MD, Study Director, Affiliation: Galderma Laboratories, L.P.
Overall contact:
Luz E Colon, MS, Phone: 817-961-5243, Email: lucy.colon@galderma.com
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.
Clinical Details
Official title: A Comparative Study of Adapalene Gel, 0.3% Versus Tretinoin 0.05% Emollient Cream, for the Treatment of Photodamage
Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Efficacy - Overall Integrated Assessment of Photodamage at week 24
Secondary outcome: 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
Detailed description:
Same as above.
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Luz E Colon, MS, Phone: 817-961-5243, Email: lucy.colon@galderma.com
University of Michigan Department of Dermatology, Ann Arbor, Michigan 48109, United States; Recruiting
Jennifer Keith, Phone: 734-936-4192, Email: jennbell@umich.edu
Dana Sachs, MD, Principal Investigator
Additional Information
Starting date: April 2008
Ending date: December 2009
Last updated: September 5, 2008
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