Skip to main content
OpenTrials
Completed

NCT Number: NCT00647556

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Photoaging

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Michigan Department of Dermatology

Ann Arbor, Michigan, 48109, United States

About this study

Same as above.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

adapalene gel, 0.3%

Drug

applied topically once daily in the evening

Other names: Differin® 0.3% Gel

tretinoin 0.05% emollient cream

Drug

applied topically once daily in the evening

Other names: tretinoin emollient cream 0.05%

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

A Comparative Study of Adapalene Gel 0.3% Versus Tretinoin 0.05% Emollient Cream, for the Treatment of Photodamage

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Mar 31, 2008
Registry last updated
Aug 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.