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

Condition(s) targeted: Photoaging

Intervention: adapalene gel, 0.3% (Drug); tretinoin 0.05% emollient cream (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Galderma Laboratories, L.P.

Official(s) and/or principal investigator(s):
Ronald W Gottschalk, MD, Study Director, Affiliation: Galderma Laboratories, L.P.

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.

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change From Baseline in Overall Integrated Assessment of Photodamage at Week 24

Secondary outcome:

Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24

Number of Participants Who Improved (a Decrease of at Least One Point) in Overall Integrated Assessment of Photodamage From Baseline to Week 12.

Number of Participants in Each Category of the Subject Evaluation of Improvement at Week 12 and Week 24

Number of Participants in Each Category of the Investigator Evaluation of Global Response (Improvement) at Week 12 and Week 24

Detailed description: Same as above.

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

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

Starting date: April 2008
Last updated: September 21, 2012