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

Phase 3

Completed

Conditions: Photoaging

Interventions: Drug: tretinoin 0.05% emollient cream
Drug: adapalene gel, 0.3%

Registration Number: NCT00647556

Lead Sponsor: Galderma R&D

Brief 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.

Detailed Description: Same as above.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tretinoin	tretinoin 0.05% emollient cream	Tretinoin
adapalene	adapalene gel, 0.3%	adapalene

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Overall Integrated Assessment of Photodamage at Week 24	baseline to week 24	Number of participants who improved (a decrease by at least one point) in Overall Integrated Assessment of Photodamage from baseline to week 24. Overall Integrated Assessment of Photodamage is a scale from 0 - 5 (0 = None, 1 = Minimal, 2 = Mild, 3 - Moderate, 4 = Severe and 5 = Very Severe) with 0 being best and 5 being worst.

Secondary Outcome Measures

Name	Time	Method
Number of Participants in Each Category of the Subject Evaluation of Improvement at Week 12 and Week 24	week 12 and week 24	Number of participants in each category of the Subject Evaluation of Improvement at week 12 and week 24. Subject Evaluation of Improvement was evaluated on a scale from 0 - 6 (0 = Complete Improvement, 1 = Almost (\~90%) Improvement, 2 = Marked (\~75%) Improvement, 3 = Moderate (\~50%) Improvement, 4 = Slight (\~25%) Improvement, 5 = No Change, 6 = Worse) with 0 being best and 6 being worst.
Number of Participants in Each Category of the Investigator Evaluation of Global Response (Improvement) at Week 12 and Week 24	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. Investigator Evaluation of Global Response (Improvement) is evaluated on a scale from 0 - 6 (0 = Complete Response, 1 = Almost Complete (\~90%) Response, 2 = Marked (\~75%) Response, 3 = Moderate (\~50%) Response, 4 = Slight (\~25%) Response, 5 = No Response and 6 = Worsening) with 0 being best and 6 being worst.
Number of Participants Who Improved (a Decrease of at Least One Point) in Overall Integrated Assessment of Photodamage From Baseline to Week 12.	baseline to week 12	Number of participants who improved in Overall Integrated Assessment of Photodamage from baseline to week 12. Overall Integrated Assessment of Photodamage was evaluated on a scale from 0 - 5 (0 = None, 1 = Minimal, 2 = Mild, 3 = Moderate 4 = Severe and 5 = Very Severe) with 0 being best and 5 being worst.
Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24	baseline, week 12 and week 24	Number of participants in each category of the Photonumeric Scale for the Assessment of Photodamage from baseline to week 12 and baseline to week 24. Photonumeric Scale consisted of 9 categories (Fine Wrinkling, Mottled Pigmentation, Irregular Depigmentation, Lentigines, Coarse Wrinkling, Elastosis, Tactile Roughness, Telangiectasia, and Actinic Keratosis. These were evaluated on a scale from 0 - 4 (0 = None, 1 = Minimal, 2 = Mild, 3 = Moderate and 4 = Severe) with 0 being best and 4 being worst.