Adapalene Gel 0.3% Versus Tretinoin 0.05% Emollient Cream for Treatment of Photodamage - Full Text View

Sponsor:	Galderma Laboratories, L.P.
Information provided by:	Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:	NCT00647556

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
Solar Elastosis	Drug: adapalene gel, 0.3% Drug: tretinoin 0.05% emollient cream	Phase III

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:

Drug Information available for: Adapalene Tretinoin

U.S. FDA Resources

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

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:	Ronald W. Gottschalk, MD / Medical Director, 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:	March 16, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Skin Diseases
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 February 12, 2012