Safety Study in Patients With Scalp Psoriasis Suppression Following Maximal Use Treatment With Topical Product

Sun Pharmaceutical Industries, Inc.3 enrolled

Overview

An Open-Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use DSXS topical product (Taro Pharmaceuticals U.S.A., Inc.) in Patients with Moderate to SevereScalp Psoriasis

* 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

Scalp Psoriasis

Interventions

DSXS topical productDRUG

treatment daily for 28 days

Eligibility

Sex: ALLMin age: 12 YearsMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male or non-pregnant, non-lactating females 12-17 years of age. 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

Number of Participants With HPA Axis Suppression

Hypothalamic Pituitary Adrenal (HPA) Axis Response to stimulation

Time frame: day 28

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.