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Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Atopic Dermatitis

NCT ID: NCT02595008

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

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-28

Study Completion Date

2017-08-25

Brief Summary

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this study is to evaluate the potential of DSXS to suppress HPA axis function in patients with moderate to severe atopic dermatitis.

Detailed Description

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The objective of this study is to evaluate the potential of DSXS to suppress HPA axis function in patients with moderate to severe atopic dermatitis.

The secondary objectives are to evaluate to evaluate adverse event (AE) profiles of DSXS administered to patients with moderate to severe atopic dermatitis.

Conditions

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Dermatitis, Atopic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DSXS topical product

treatment with DSXS twice daily for 28 days

Group Type EXPERIMENTAL

DSXS

Intervention Type DRUG

Active treatment

Interventions

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DSXS

Active treatment

Intervention Type DRUG

Other Intervention Names

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Active

Eligibility Criteria

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Inclusion Criteria

* Patients with a definite clinical diagnosis of stable atopic dermatitis

Exclusion Criteria

* Patient is under the age of 2
Minimum Eligible Age

2 Years

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

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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DSXS 1502

Identifier Type: -

Identifier Source: org_study_id