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

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.

Study Type: Interventional

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

Study Primary Completion Date: September 2009

Same as above.

Intervention(s) in this Clinical Trial

• Drug: adapalene gel, 0.3%
  • applied topically once daily in the evening
• Drug: tretinoin 0.05% emollient cream
  • applied topically once daily in the evening

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: adapalene
  • adapalene
• Active Comparator: tretinoin
  • Tretinoin

Primary Measures

• Efficacy - Overall Integrated Assessment of Photodamage at week 24
  • Time Frame: 24 weeks
    Safety Issue?: No

Secondary 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
    Safety Issue?: No

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Galderma Laboratories, L.P.

Overall Clinical Trial Officials and Contacts

Ronald W Gottschalk, MD Study Director Galderma Laboratories, L.P.  

Overall Contact: Luz E Colon, MS 817-961-5243 lucy.colon@galderma.com

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00647556

Study ID Number: US10067

ClinicalTrials.gov Identifier: NCT00647556

Health Authority: United States: Food and Drug Administration