Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment With DSXS

Sun Pharmaceutical Industries, Inc.24 enrolled

Overview

An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment with DSXS .

Evaluate the potential of DSXS topical product to suppress HPA axis function in patients with moderate to severe scalp psoriasis. Evaluate the efficacy parameters and adverse event (AE) profiles of DSXS topical product administered to patients with moderate to severe scalp psoriasis.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Psoriasis

Interventions

DSXS Topical productDRUG

once daily for 28 days

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male or non-pregnant, non-lactating females 18 years of age or older. * IRE-approved, signed informed consent form that meets all criteria of current FDA regulations. Exclusion Criteria: * Females who are pregnant, nursing, planning to become pregnant during the duration of the study, or if of child-bearing potential and sexually active and not prepared to use appropriate contraceptive methods to avoid pregnancy.

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 stimulation

Time frame: 28 days

Data from ClinicalTrials.gov

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