Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone (DSXS) With Atopic Dermatitis

Phase 3

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: DSXS; Drug: Placebo

• Registration Number: NCT02595073
• Lead Sponsor: Taro Pharmaceuticals USA

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

Study Timeline

• Study Start: 2015-09-04
• Study First Submitted: 2015-11-01
• Study First Submitted QC: 2015-11-01
• Study First Posted: 2015-11-03
• Primary Completion: 2017-01-17
• Study Completion: 2017-08-29
• Results First Submitted: 2018-11-12
• Status Verified: 2018-12
• Results First Submitted QC: 2018-12-05
• Last Update Submitted: 2018-12-05
• Results First Posted: 2018-12-07
• Last Update Posted: 2018-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• male and non-pregnant females, age 6 months or older, with a confirmed diagnosis of moderate to severe atopic dermatitis (AD)

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Exclusion Criteria

• Lacks stable diagnosis of atopic dermatitis or has been diagnosed with mild atopic dermatitis.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DSXS topical product	DSXS	DSXS Active treatment
Placebo topical product	Placebo	Placebo treatment

Primary Outcome Measures

Name	Time	Method
The Number of Patients in Each Treatment Group That Have Clinical Success	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 Outcome Measures

Name	Time	Method
Change From Baseline in %BSA Affected at Day 28 ± 2	28 days	The change in %BSA Affected from Visit 1 Baseline (Day 1) to Visit 4 End of Treatment (Day 28 ± 2)

Trial Locations

Locations (1)

Taro Pharmaceuticals USA Inc.; 🇺🇸 Hawthorne, New York, United States