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

Taro Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: Placebo; Drug: DSXS

Study type: Interventional

Funder types: Industry

Identifiers

NCT02595073

DSXS 1504

Details and patient eligibility

About

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

Full 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

Enrollment: 124 patients

Sex: All

Ages: 6+ months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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124 participants in 2 patient groups, including a placebo group

DSXS topical product

Experimental group

Description:

DSXS Active treatment

Treatment:

Drug: DSXS

Placebo topical product

Placebo Comparator group

Description:

Placebo treatment

Treatment:

Drug: Placebo