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NCT02595008 Clinical Trial

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

Dermatitis, Atopic Clinical Trial

Official title:
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression and Pharmacokinetics Following Maximal Use Treatment With DSXS in Patients With Atopic Dermatitis.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02595008
Other study ID # DSXS 1502
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date August 28, 2015
Est. completion date August 25, 2017

Study information
Verified date December 2018
Source Taro Pharmaceuticals USA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date August 25, 2017
Est. primary completion date February 22, 2017
Accepts healthy volunteers No
Gender All
Age group 2 Years and older
Eligibility Inclusion Criteria:

- Patients with a definite clinical diagnosis of stable atopic dermatitis

Exclusion Criteria:

- Patient is under the age of 2

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• DSXS
Active 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 Number of Participants With HPA Axis Suppression Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression at the end of treatment. HPA Axis suppression is defined as a 30 minute post CortrosynTM injection level cortisol level of = 18 mcg/100ml. 28 days.
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