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

Atopic Dermatitis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02595073
• Other study ID #: DSXS 1504
• Status: Completed
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

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