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NCT02932878 Clinical Trial

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

Plaque Psoriasis Clinical Trial

Official title:
An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS Topical Product in Patients With Plaque Psoriasis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02932878
Other study ID # DSXS 1503a
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2, 2016
Est. completion date October 16, 2017

Study information
Verified date November 2018
Source Taro Pharmaceuticals USA
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date October 16, 2017
Est. primary completion date April 10, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 18 Years
Eligibility Inclusion Criteria:

- Male or non pregnant, non lactating females

Exclusion Criteria:

- Patients under 2 years of age

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• DSXS topical
topical treatment

Locations
Country Name City State
United States Taro Pharmaceuticals USA Inc. Hawthorne New York

Sponsors (1)
Lead Sponsor Collaborator
Taro Pharmaceuticals USA

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of Patients in the Study With HPA Axis Suppression Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin 28 Days
See also
  Status Clinical Trial Phase
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Recruiting NCT06030076 - A Study to Assess the Effects of Switching From a Biologic Treatment to Tildrakizumab Using Patient-reported Outcomes in Adult Participants With Moderate to Severe Plaque Psoriasis
Completed NCT04263610 - Efficacy and Safety of Tildrakizumab in Participants With Moderate-to-Severe Chronic Plaque Psoriasis Who Are Non-Responders to Dimethyl Fumarate Therapy Phase 4
Completed NCT02601469 - Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Plaque Psoriasis Phase 2
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