An Open Label, Safety Study to Assess the Potential for Adrenal Suppression

Sun Pharmaceutical Industries, Inc.16 enrolled

Overview

An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Treatment with DSXS (Taro Pharmaceuticals U.S.A., Inc.) in Patients with Plaque Psoriasis

To evaluate the potential of DSXS to suppress HPA axis function in patients with mild to moderate plaque psoriasis. To evaluate the efficacy parameters and adverse event (AE) profile of DSXS administered to patients with mild to moderate plaque psoriasis.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Plaque Psoriasis

Interventions

DSXS topicalDRUG

topical treatment

Eligibility

Sex: ALLMin age: 2 YearsMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male or non pregnant, non lactating females Exclusion Criteria: * Patients under 2 years of age

Locations (1)

Taro Pharmaceuticals USA Inc.

Hawthorne, New York, United States

Outcomes

Primary Outcomes

Proportion of Patients in the Study With HPA Axis Suppression

Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin

Time frame: 28 Days

Data from ClinicalTrials.gov

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