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

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.

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

• Change From Baseline in Overall Integrated Assessment of Photodamage at Week 24
  • Time Frame: baseline to week 24
    Safety Issue?: No

Secondary Measures

• Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24
  • Time Frame: baseline, week 12 and week 24
    Safety Issue?: No
• Number of Participants Who Improved (a Decrease of at Least One Point) in Overall Integrated Assessment of Photodamage From Baseline to Week 12.
  • Time Frame: baseline to week 12
    Safety Issue?: No
• Number of Participants in Each Category of the Subject Evaluation of Improvement at Week 12 and Week 24
  • Time Frame: week 12 and week 24
    Safety Issue?: No
• Number of Participants in Each Category of the Investigator Evaluation of Global Response (Improvement) at Week 12 and Week 24
  • Time Frame: week 12 and week 24
    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 Investigator: Galderma Laboratories, L.P. Industry

Overall Clinical Trial Officials and Contacts

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

Information obtained from ClinicalTrials.gov on February 12, 2012

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