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

Study Overview
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Brief Summary
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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
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Same as above.

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

Conditions
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Photoaging

Intervention / Treatment
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* Drug: adapalene gel, 0.3%
* Drug: tretinoin 0.05% emollient cream


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: adapalene<br>adapalene | Drug: adapalene gel, 0.3%<br>* applied topically once daily in the evening<br>* Other names: Differin® 0.3% Gel;|
| Active Comparator: tretinoin<br>Tretinoin | Drug: tretinoin 0.05% emollient cream<br>* applied topically once daily in the evening<br>* Other names: tretinoin emollient cream 0.05%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline to week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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 | 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. | week 12 and week 24 |