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NCT02933528 Clinical Trial

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

Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02933528
Other study ID # DSXS 1538a
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date July 11, 2016
Est. completion date November 27, 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 Maximal Use Treatment with DSXS .

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.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date November 27, 2017
Est. primary completion date August 11, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• DSXS Topical product
once daily for 28 days

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 stimulation 28 days
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