Combination Therapy With Differin® Gel 0.3% and Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris
A Clinical Assessment of Combination Therapy With Differin® Gel, 0.3% With Duac® (Clindamycin/Benzoyl Peroxide Gel) in Subjects With Acne Vulgaris
1 other identifier
interventional
100
1 country
4
Brief Summary
This study is to determine the efficacy and safety of 12 week treatment with Differin® Gel 0.3% applied in the evening, in combination with Duac® (Clindamycin/Benzoyl Peroxide Gel) applied in the morning, in Subjects with Acne vulgaris.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Dec 2007
Shorter than P25 for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 30, 2008
CompletedFirst Posted
Study publicly available on registry
May 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedResults Posted
Study results publicly available
March 16, 2016
CompletedAugust 23, 2022
February 1, 2016
8 months
April 30, 2008
August 12, 2014
July 28, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in Total Lesion Counts
6 and 12 weeks
Secondary Outcomes (6)
Global Severity Assessment Success
6 and 12 weeks
Global Assessment of Improvement From Baseline
12 weeks
Worst Post Baseline Tolerability Assessment - Erythema
12 weeks
Worst Post Baseline Tolerability Assessment - Scaling
12 weeks
Worst Post Baseline Tolerability Assessment - Dryness
12 weeks
- +1 more secondary outcomes
Study Arms (1)
Study Treatment
EXPERIMENTALadapalene gel, 0.3% Other Names: Differin® Gel, 0.3% Applied once daily at bedtime clindamycin/benzoyl peroxide gel Other Names: Duac® Gel Applied once daily in the morning
Interventions
Applied once daily at bedtime
Applied once daily in the morning
Eligibility Criteria
You may qualify if:
- Subjects with a minimum of 20 inflammatory lesions on the face;
- Subjects with a minimum of 15 and a maximum of 100 non-inflammatory lesions (open and closed comedones) on the face, excluding the nose;
- Subject has a Global Severity Assessment
You may not qualify if:
- \. Subjects with more than three nodulo-cystic lesions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (4)
Center for Dermatology and Laser Surgery
Sacramento, California, 95819, United States
Derm Research, P.L.L.C.
Louisville, Kentucky, 40217, United States
Brodell Medical
Warren, Ohio, 44483, United States
Northwest Cutaneous Research Specialists
Portland, Oregon, 97210, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Elizabeth M Nieman
- Organization
- Galderma Laboratories, L.P.
Study Officials
- STUDY DIRECTOR
Ron W Gottschalk, MD
Galderma R&D
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2008
First Posted
May 5, 2008
Study Start
December 1, 2007
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
August 23, 2022
Results First Posted
March 16, 2016
Record last verified: 2016-02
Data Sharing
- IPD Sharing
- Will not share