A Study Comparing Aczone® Plus Differin® Versus Duac® Plus Differin® in Patients With Severe Facial Acne
Information source: Allergan
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acne Vulgaris
Intervention: Dapsone plus Adapalene (Drug); Clindamycin/benzoyl peroxide plus Adapalene (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Allergan Official(s) and/or principal investigator(s): Medical Director, Study Director, Affiliation: Allergan
Summary
A study comparing the topical application of Aczone® plus Differin® versus Duac® plus
Differin® in patients with severe facial acne (facial acne vulgaris).
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: Percentage of Participants With at Least a One Point Decrease in the Global Acne Assessment Score (GAAS) at Week 12
Secondary outcome: Change From Baseline in Global Acne Assessment Score (GAAS) at Week 12Percentage of Participants at Week 12 Having at Least a One Point Decrease in Overall Disease Severity Percent Change From Baseline in Inflammatory Lesion Counts at Week 12 Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12 Percent Change From Baseline in Total Lesion Count at Week 12 Percentage of Participants Demonstrating a ≥ 1 Category Increase in Tolerability From Baseline at Week 12
Eligibility
Minimum age: 18 Years.
Maximum age: 40 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Severe facial acne (acne vulgaris)
Exclusion Criteria:
- History of significant anemia or hemolysis
- History of enteritis (eg, regional enteritis, ulcerative colitis, pseudomembranous
colitis, antibiotic-associated colitis)
- History of lupus, rosacea, or seborrheic dermatitis
Locations and Contacts
Miramar, Florida, United States
Additional Information
Starting date: August 2010
Last updated: June 25, 2012
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