Acne Vulgaris
Conditions
Brief summary
This study will assess the safety, tolerability, and efficacy of dapsone in subjects with acne vulgaris following 12 weeks of treatment.
Interventions
Dapsone Formulation A applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
Dapsone Formulation B applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
Dapsone Formulation C applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
DRUGDapsone 5% Gel
Dapsone 5% gel (ACZONE®) applied twice daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Participation in Allergan study 225678-004
Exclusion criteria
* Anticipates the need for surgery or hospitalization during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline in Inflammatory Lesion Count | Baseline, Week 12 |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Non-Inflammatory Lesion Count | Baseline, Week 12 |
| Change from Baseline in Total Lesion Count | Baseline, Week 12 |
| Percentage of Subjects With a Global Acne Assessment Score (GAAS) of 0 or 1 | Week 12 |
Outcome results
None listed