Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine


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%




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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

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


Locations
Layout table for location information
United States, Michigan
University of Michigan Department of Dermatology
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
Galderma Laboratories, L.P.
Investigators
Layout table for investigator information
Study Director: Ronald W Gottschalk, MD Galderma Laboratories, L.P.
Layout table for additonal information
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
Additional relevant MeSH terms:
Layout table for 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