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

Sun Pharmaceutical Industries, Inc.124 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

124

Conditions

Atopic Dermatitis

Interventions

DSXSDRUG

Active treatment

PlaceboDRUG

Placebo treatment

Eligibility

Sex: ALLMin age: 6 Months

Medical Language ↔ Plain English

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.

Locations (1)

Taro Pharmaceuticals USA Inc.

Hawthorne, New York, United States

Outcomes

Primary Outcomes

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

Time frame: 28 days

Secondary Outcomes

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)

Time frame: 28 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.