Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Plaque Psoriasis

Plaque Psoriasis Clinical Trial

Official title:

An Open Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment With DSXS (Taro Pharmaceuticals U.S.A., Inc.) in Patients With Plaque Psoriasis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02601469
• Other study ID #: DSXS 1503
• Status: Completed
• Phase: Phase 2
• Start date: September 4, 2015
• Est. completion date: August 25, 2017

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 treatment with DSXS administered twice daily for 28 days in patients with moderate to severe plaque psoriasis.

Description:

1. The objective of this study is to evaluate the potential of DSXS to suppress HPA axis function in patients with moderate to severe plaque psoriasis

2. To evaluate the efficacy parameters, pharmacokinetics and adverse event (AE) profile of DSXS

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: August 25, 2017
• Est. primary completion date: December 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

1. Patients with a confirmed diagnosis of plaque psoriasis, patients 2-17 years of age with = 10% BSA affected and patients age 18 years of age or older with = 20% BSA affected

2. Investigator Global Assessment (IGA) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity.

3. Results from a cortisol response test that are considered normal and show no evidence of any abnormal HPA function or adrenal response

Exclusion Criteria:

1. Patients under 2 years of age.

2. Investigator Global Assessment (IGA) of less than 3 (moderate) or greater than 4 (severe) at baseline.

3. Current diagnosis of types of psoriasis other than stable plaque psoriasis (i.e., erythrodermic, exfoliative or pustular psoriasis).

4. Results from a cortisol response test that show evidence of any abnormal HPA function or adrenal response

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Drug:
• DSXS
twice 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 Cosyntropin demonstrating the absence or presence of adrenal suppression at the end of treatment. HPA Axis suppression is defined as a 30 minute post CortrosynTM injection level cortisol level of = 18 mcg/100ml.	28 days