Adapalene Gel 0.3% Versus Tretinoin 0.05% Emollient Cream for Treatment of Photodamage
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ClinicalTrials.gov Identifier: NCT00647556 |
Recruitment Status :
Completed
First Posted : March 31, 2008
Results First Posted : February 24, 2011
Last Update Posted : October 2, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Photoaging | Drug: adapalene gel, 0.3% Drug: tretinoin 0.05% emollient cream | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Comparative Study of Adapalene Gel 0.3% Versus Tretinoin 0.05% Emollient Cream, for the Treatment of Photodamage |
Study Start Date : | April 2008 |
Actual Primary Completion Date : | January 2010 |
Actual Study Completion Date : | January 2010 |

Arm | Intervention/treatment |
---|---|
Active Comparator: adapalene
adapalene
|
Drug: adapalene gel, 0.3%
applied topically once daily in the evening
Other Name: Differin® 0.3% Gel |
Active Comparator: tretinoin
Tretinoin
|
Drug: tretinoin 0.05% emollient cream
applied topically once daily in the evening
Other Name: tretinoin emollient cream 0.05% |
- Change From Baseline in Overall Integrated Assessment of Photodamage at Week 24 [ Time Frame: 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.
- 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 ]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.
- 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 ]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.
- 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 ]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 [ Time Frame: 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.

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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00647556
United States, Michigan | |
University of Michigan Department of Dermatology | |
Ann Arbor, Michigan, United States, 48109 |
Study Director: | Ronald W Gottschalk, MD | Galderma Laboratories, L.P. |
Responsible Party: | Galderma Laboratories, L.P. |
ClinicalTrials.gov Identifier: | NCT00647556 |
Other Study ID Numbers: |
US10067 |
First Posted: | March 31, 2008 Key Record Dates |
Results First Posted: | February 24, 2011 |
Last Update Posted: | October 2, 2012 |
Last Verified: | September 2012 |
Adapalene Tretinoin Emollients Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Dermatologic Agents Antineoplastic Agents Keratolytic Agents |