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

Scalp Psoriasis Clinical Trial

Official title:

An Open-label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment With DSXS 1538b Topical Product Applied Once-daily in Patients With Moderate to Severe Scalp Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02933502
• Other study ID #: DSXS 1538b
• Status: Completed
• Phase: Phase 2
• Start date: July 11, 2016
• Est. completion date: January 2, 2018

Study information

• Verified date: December 2018
• Source: Taro Pharmaceuticals USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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: 3
• Est. completion date: January 2, 2018
• Est. primary completion date: September 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis
• Scalp Psoriasis

Intervention

Drug:
• DSXS topical product
treatment 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	Number of Participants With HPA Axis Suppression	Hypothalamic Pituitary Adrenal (HPA) Axis Response to stimulation	day 28