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

Galderma R&D30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Photoaging

Interventions

adapalene gel, 0.3%DRUG

applied topically once daily in the evening

tretinoin 0.05% emollient creamDRUG

applied topically once daily in the evening

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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 (1)

University of Michigan Department of Dermatology

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Change From Baseline in Overall Integrated Assessment of Photodamage at 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.

Time frame: baseline to week 24

Secondary Outcomes

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

Time frame: baseline, week 12 and 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 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.

Time frame: 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 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.

Data from ClinicalTrials.gov

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