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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02595073
Other study ID # DSXS 1504
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 4, 2015
Est. completion date August 29, 2017

Study information

Verified date December 2018
Source Taro Pharmaceuticals USA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Efficacy and Safety of DSXS (Taro Pharmaceuticals, U.S.A., Inc.) in Patients with Moderate to Severe Atopic Dermatitis


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


Recruitment information / eligibility

Status Completed
Enrollment 124
Est. completion date August 29, 2017
Est. primary completion date January 17, 2017
Accepts healthy volunteers No
Gender All
Age group 6 Months and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
DSXS
Active treatment
Placebo
Placebo treatment

Locations

Country Name City State
United States Taro Pharmaceuticals USA Inc. Hawthorne New York

Sponsors (1)

Lead Sponsor Collaborator
Taro Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Number of Patients in Each Treatment Group That Have Clinical Success 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 28 days
Secondary Change From Baseline in %BSA Affected at Day 28 ± 2 The change in %BSA Affected from Visit 1 Baseline (Day 1) to Visit 4 End of Treatment (Day 28 ± 2) 28 days
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