Phase 3
N=30
Adapalene Gel 0.3% Versus Tretinoin 0.05% Emollient Cream for Treatment of Photodamage
Photoaging
Bottom Line
View on ClinicalTrials.gov: NCT00647556 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Feb 2011
Primary outcome: Primary: Change From Baseline in Overall Integrated Assessment of Photodamage at Week 24 — 6; 10 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- adapalene gel, 0.3% (Drug); tretinoin 0.05% emollient cream (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Overall Integrated Assessment of Photodamage at Week 24 |
6; 10 | — |
| SECONDARY Photonumeric Scale for the Assessment of Photodamage From Baseline to Week 12 and Baseline to Week 24 |
0; 0; 0; 0; 3; 2 | — |
| SECONDARY Number of Participants Who Improved (a Decrease of at Least One Point) in Overall Integrated Assessment of Photodamage From Baseline to Week 12. |
6; 4 | — |
| SECONDARY Number of Participants in Each Category of the Subject Evaluation of Improvement at Week 12 and Week 24 |
0; 0; 0; 0; 4; 2 | — |
| SECONDARY Number of Participants in Each Category of the Investigator Evaluation of Global Response (Improvement) at Week 12 and Week 24 |
0; 0; 0; 0; 0; 1 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00647556). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.