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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 12

Percentage 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

Page last updated: August 23, 2015

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