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

• ClinicalTrials.gov Identifier: NCT00647556
• Recruitment Status: Completed
• First Posted: March 31, 2008
• Results First Posted: February 24, 2011
• Last Update Posted: October 2, 2012
• Sponsor: Galderma Laboratories, L.P.
• Information provided by (Responsible Party): Galderma Laboratories, L.P.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Photoaging	Drug: adapalene gel, 0.3%; Drug: tretinoin 0.05% emollient cream	Phase 3

Detailed Description:

Same as above.

Study Design

• 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

Arms and Interventions

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%

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Michigan

University of Michigan Department of Dermatology

Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

Galderma Laboratories, L.P.

Investigators

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

More Information

• Responsible Party: Galderma Laboratories, L.P.
• ClinicalTrials.gov Identifier: NCT00647556
• Other Study ID Numbers: US10067
• First Posted: March 31, 2008
• Results First Posted: February 24, 2011
• Last Update Posted: October 2, 2012
• Last Verified: September 2012

Additional relevant MeSH terms:

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