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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:
NCT00647556
First received: March 26, 2008
Last updated: September 21, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Photoaging
Drug: adapalene gel, 0.3%
Drug: tretinoin 0.05% emollient cream
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Galderma Laboratories, L.P.:

Primary Outcome Measures:
  • Change From Baseline in Overall Integrated Assessment of Photodamage at Week 24 [ Time Frame: baseline to week 24 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 30
Study Start Date: April 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%

Detailed Description:

Same as above.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00647556

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

No publications provided

Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT00647556     History of Changes
Other Study ID Numbers: US10067
Study First Received: March 26, 2008
Results First Received: January 28, 2011
Last Updated: September 21, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Emollients
Tretinoin
Adapalene
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents
Keratolytic Agents
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
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 27, 2014