Acne Vulgaris
Conditions
Brief summary
Multi-center, double-blind, randomized, placebo-controlled trial of Dapsone 5.0% Gel in the treatment of acne vulgaris.
Detailed description
Multi-center, double-blind, randomized, placebo-controlled trial of Dapsone 5.0% Gel in the treatment of acne vulgaris for 84 days in male and female subjects age 12-40.
Interventions
DRUGDapsone 5.0% Gel (SEEGPharm)
Topical Gel
OTHERPlacebo
Topical Gel
DRUGDapsone 5.0% Gel (Allergan)
Topical Gel
Sponsors
Seegpharm S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Healthy male or non-pregnant females aged ≥ 12 and ≤ 40 years of age with a clinical diagnosis of acne vulgaris. * Informed Consent/Assent: For subjects 12 to 17 years of age inclusive must have provided Institutional Review Board (IRB) approved written assent that must be accompanied by an IRB approved written consent from the subject's legally acceptable representatives (i.e., parent or guardian). In addition, all subjects or their legally acceptable representatives must sign a Health Insurance Portability and Accountability Act (HIPAA) authorization. * On the face, subjects must have ≥ 20 inflammatory lesions (i.e., papules and pustules), AND ≥ 25 non-inflammatory lesions (open and closed comedones) AND ≤ 2 nodulocystic lesions (i.e., nodules and cysts). For the purposes of study treatment and evaluation, all lesions on the face should be counted, including those on the nose. Subjects may have acne lesions on other areas of the body (e.g., back, chest, and arms) which should be excluded from the count, treatment and the IGA evaluation. * Subjects must have an acne severity grade of 3 or 4 per the IGA * Subjects must be willing to refrain from using all other topical acne medications or antibiotics during the 12-week treatment period other than the study drug.
Exclusion criteria
* Prior or current concomitant therapies that would interfere with assessments in the study. * Prior or current concomitant therapies skin conditions that would interfere with assessments in the study. * Prior, current or planned procedures that would interfere with assessments in the study. * Current or planned activities that would interfere with assessment in the study. * Subjects who have a Baseline local skin site reaction score of 3 \[severe (marked/intense)\] for any signs and/or symptoms of irritation as scored using the local skin site reaction scores.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparisons of Active Products: Mean percent change in the inflammatory lesion (papules and pustules) counts and non-inflammatory lesion (open and closed comedones) counts | Treatment Days: 84 days of dosing | To compare Dapsone 5% Gel (SEEGPharm) to Aczone® (Allergan's Dapsone 5% Gel) to the Placebo-Vehicle control with respect to the mean percent change in the inflammatory lesion (papules and pustules) counts and non-inflammatory lesion (open and closed comedones) counts, from Baseline (Visit 1/ Day1) to End-of-Treatment (EOT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Success: Proportion of subjects with a clinical response of success | 12 Weeks | To evaluate as the proportion of subjects with a clinical response of success at Week 12. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Outcomes: Incidence of Adverse Events | Baseline (Day 1) to Week 12 (Day 85) | Analysis of the incidence of Adverse Events from Baseline (Day 1) to Week 12 (Day 85) |
| Safety Outcomes: Change in Vital Signs | Baseline (Day 1) to Week 12 (Day 85) | Clinically Significant Changes in Body temperature (oral), pulse rate (sitting), blood pressure (sitting systolic and diastolic) from Baseline (Day 1) to Week 12 (Day 85) |
| Safety Outcomes: Local Skin/Application Site Reaction Scores | Baseline (Day 1) to Week 12 (Day 85) | Application (local skin) sites will be assessed at each visit and scored using the local skin site reaction scores (0=Absent, 1=Mild, 2=Moderate, 3=Severe) for the following signs and symptoms of irritation: erythema, dryness, burning/stinging, erosion, edema, pain, and itching, for comparisons between groups. |
Countries
Belize, United States
Outcome results
None listed