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

NCT ID: NCT02595073

Last Updated: 2018-12-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-04

Study Completion Date

2017-08-29

Brief Summary

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

Detailed Description

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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

Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DSXS topical product

DSXS Active treatment

Group Type EXPERIMENTAL

DSXS

Intervention Type DRUG

Active treatment

Placebo topical product

Placebo treatment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo treatment

Interventions

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DSXS

Active treatment

Intervention Type DRUG

Placebo

Placebo treatment

Intervention Type DRUG

Other Intervention Names

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Active vehicle

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Pharmaceutical Industries, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novum Pharmaceutical Research Services

Role: STUDY_CHAIR

http://www.novumprs.com/contact

Locations

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Taro Pharmaceuticals USA Inc.

Hawthorne, New York, United States

Site Status

Countries

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United States

Other Identifiers

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DSXS 1504

Identifier Type: -

Identifier Source: org_study_id