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

Sun Pharmaceutical Industries, Inc.24 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dermatitis, Atopic

Interventions

DSXSDRUG

Active treatment

Eligibility

Sex: ALLMin age: 2 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with a definite clinical diagnosis of stable atopic dermatitis Exclusion Criteria: * Patient is under the age of 2

Locations (1)

Taro Pharmaceuticals USA Inc.

Hawthorne, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 28 days.

Data from ClinicalTrials.gov

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