A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of DSXS in Patients With Moderate to Severe Atopic Dermatitis.
Overview
- Phase
- Phase 3
- Intervention
- DSXS
- Conditions
- Atopic Dermatitis
- Sponsor
- Taro Pharmaceuticals USA
- Enrollment
- 124
- Locations
- 1
- Primary Endpoint
- The Number of Patients in Each Treatment Group That Have Clinical Success
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
Efficacy and Safety of DSXS (Taro Pharmaceuticals, U.S.A., Inc.) in Patients with Moderate to Severe Atopic Dermatitis
Detailed Description
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of DSXS (Taro Pharmaceuticals, U.S.A., Inc.) in Patients with Moderate to Severe Atopic Dermatitis
Investigators
Eligibility Criteria
Inclusion Criteria
- •male and non-pregnant females, age 6 months or older, with a confirmed diagnosis of moderate to severe atopic dermatitis (AD)
Exclusion Criteria
- •Lacks stable diagnosis of atopic dermatitis or has been diagnosed with mild atopic dermatitis.
Arms & Interventions
DSXS topical product
DSXS Active treatment
Intervention: DSXS
Placebo topical product
Placebo treatment
Intervention: Placebo
Outcomes
Primary Outcomes
The Number of Patients in Each Treatment Group That Have Clinical Success
Time Frame: 28 days
Clinical Success defined using the following scores at Visit 4 (Day 28 ± 2): At least a 2-grade improvement from the baseline IGA score (i.e., clear \[0\] or almost clear \[1\]) AND A score of clear or mild (0 or 1) for both erythema and induration/papulation/edema
Secondary Outcomes
- Change From Baseline in %BSA Affected at Day 28 ± 2(28 days)