Phase 4
N=286
A Study Comparing Aczone® Plus Differin® Versus Duac® Plus Differin® in Patients With Severe Facial Acne
Acne Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT01231334 ↗Enrolled (actual)
286
Serious AEs
0.0%
Results posted
Jul 2012
Primary outcome: Primary: Percentage of Participants With at Least a One Point Decrease in the Global Acne Assessment Score (GAAS) at Week 12 — 69.7; 81.4 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dapsone plus Adapalene (Drug); Clindamycin/benzoyl peroxide plus Adapalene (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Allergan
- Primary completion
- Jun 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least a One Point Decrease in the Global Acne Assessment Score (GAAS) at Week 12 |
69.7; 81.4 | — |
| SECONDARY Change From Baseline in Global Acne Assessment Score (GAAS) at Week 12 |
2.80; 2.84; -0.87; -1.27 | — |
| SECONDARY Percentage of Participants at Week 12 Having at Least a One Point Decrease in Overall Disease Severity |
83.5; 92.4 | — |
| SECONDARY Percent Change From Baseline in Inflammatory Lesion Counts at Week 12 |
-70.7; -75.9 | — |
| SECONDARY Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12 |
-55.3; -60.7 | — |
| SECONDARY Percent Change From Baseline in Total Lesion Count at Week 12 |
-62.7; -65.0 | — |
| SECONDARY Percentage of Participants Demonstrating a ≥ 1 Category Increase in Tolerability From Baseline at Week 12 |
21.3; 11.9; 11.5; 9.3; 6.7; 6.0 | — |
Summary
A study comparing the topical application of Aczone® plus Differin® versus Duac® plus Differin® in patients with severe facial acne (facial acne vulgaris).
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01231334). 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.