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

  Purpose

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

Condition Intervention Phase
Psoriasis Drug: DSXS Topical product Phase 2

Study Type: Interventional
Study Design:Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title:An Open-Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment With DSXS in Patients With Moderate to Severe Scalp Psoriasis

Resource links provided by NLM:

Further study details as provided by Taro Pharmaceuticals USA:

Primary Outcome Measures:

  • Proportion of patients in the study with HPA axis suppression [ Time Frame: 28 days ]
    Hypothalamic Pituitary Adrenal (HPA) Axis Response to stimulation

Estimated Enrollment:20
Actual Study Start Date:July 11, 2016
Estimated Study Completion Date:December 2018
Estimated Primary Completion Date:November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dsxs topical product

treatment with DSXS once daily for 28 days
Drug: DSXS Topical product

once daily for 28 days
Other Name: Active

Detailed Description:

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.

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