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

Taro Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Plaque Psoriasis

Treatments

Drug: DSXS

Study type

Interventional

Funder types

Industry

Identifiers

NCT02601469

DSXS 1503

Details and patient eligibility

About

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.

Full description

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

Enrollment

26 patients

Sex

All

Ages

2+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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
Investigator Global Assessment (IGA) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity.
Results from a cortisol response test that are considered normal and show no evidence of any abnormal HPA function or adrenal response

Exclusion criteria

Patients under 2 years of age.
Investigator Global Assessment (IGA) of less than 3 (moderate) or greater than 4 (severe) at baseline.
Current diagnosis of types of psoriasis other than stable plaque psoriasis (i.e., erythrodermic, exfoliative or pustular psoriasis).
Results from a cortisol response test that show evidence of any abnormal HPA function or adrenal response