A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of DSXS in Patients With Mild to Moderate Plaque Psoriasis
Overview
- Phase
- Phase 3
- Intervention
- DSXS
- Conditions
- Plaque Psoriasis
- Sponsor
- Taro Pharmaceuticals USA
- Enrollment
- 119
- Locations
- 1
- Primary Endpoint
- Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the therapeutic efficacy and safety of DSXS compared to a Placebo (vehicle) in patients with mild to moderate plaque psoriasis.
Detailed Description
To evaluate the therapeutic efficacy and safety of dsxs topical spray, 0.15% (Taro Pharmaceuticals, U.S.A., Inc.) compared to a Placebo (vehicle) spray (Taro Pharmaceuticals, U.S.A., Inc.) in patients with mild to moderate plaque psoriasis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •male and non-pregnant females, 12 years of age or older, with a confirmed diagnosis of mild to moderate plaque psoriasis
Exclusion Criteria
- •patient is\< 12 years old.
Arms & Interventions
DSXS1505
To evaluate the therapeutic efficacy and safety of DSXS topical spray, 0.15%.
Intervention: DSXS
DSXS1505
To evaluate the therapeutic efficacy and safety of DSXS topical spray, 0.15%.
Intervention: Placebo
Placebo
Eligible patients will be randomized in a 1:1 ratio to Test or Placebo product.
Intervention: DSXS
Placebo
Eligible patients will be randomized in a 1:1 ratio to Test or Placebo product.
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2
Time Frame: 28 Days
The number of patients in each treatment group that have clinical success. Clinical Success is at least a 2-grade improvement from the baseline IGA score. The minimum IGA value is 0, and maximum value is 5. A higher number represents a more severe case of plaque psoriasis. Patients are required to have an IGA score of 2 or 3 at baseline, so all clinical success IGA scores will be either 0 or 1.
Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2
Time Frame: 28 Days
The number of patients in each treatment group that have Treatment Success for the Target Lesion based on the TLSS sub-scale scores. Treatment Success is defined as a score of 0 or 1 for each of the three signs and symptoms (erythema, scaling and plaque elevation) for the Target Lesion. Each score has a minimum value of 0 and maximum value of 5, where a higher value represents a more severe sign or symptom. To be considered for inclusion in the study, the Target Lesion must have a plaque elevation score of at least 2.
Secondary Outcomes
- Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 (Patients With a Baseline IGA Score of 3)(28 Days)
- Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 (Patients With a Baseline IGA Score of 3)(28 Days)
- Number of Patients in Each Treatment That Have Clinical Success Based on IGA at Day 28 ± 2 (Patients With a Baseline IGA Score of 2)(28 Days)
- Number of Patients in Each Treatment That Have Treatment Success Based on TLSS at Day 28 ± 2 (Patients With a Baseline IGA Score of 2)(28 Days)