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

Completed · Phase 2

Conditions studied: Plaque Psoriasis

In brief

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.

Key facts

Study ID

NCT02601469

Run by

Sun Pharmaceutical Industries, Inc.

People needed

26

Starts

2015-09-04

Expected to finish

2017-08-25

Last updated by the study team

2018-12-07

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Taro Pharmaceuticals USA Inc. — Hawthorne, New York, United States

Full record on ClinicalTrials.gov

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