Adrenal Suppression and Pharmacokinetics of Topicort® Spray, 0.25% in Pediatric Patients With Plaque Psoriasis

• Status: Completed
• Trial end date: 2020-03-27
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to evaluate the potential of Topicort® (desoximetasone) Topical Spray, 0.25% to suppress hypothalmic pituitary adrenal axis function. The secondary objectives are to evaluate the efficacy parameters, pharmacokinetics and adverse event profile.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Taro Pharmaceuticals USA
• Treatments: Desoximetasone

Criteria

Inclusion Criteria:

• Patients aged 7 years and older must have provided written assent accompanied by written informed consent from patient's representative

• Clinical diagnosis of stable plaque psoriasis with involvement of ≥ 10% body surface area (excluding face and scalp)

• Physicians Global Assessment score of 3 or 4 at baseline

Exclusion Criteria:

• Has other dermatological conditions that may interfere with clinical assessments

• Allergy or sensitivity to corticosteroids or any drug hypersensitivity or intolerance that would compromise patient safety or study results

• History of an adverse reaction to Cortrosyn™ or similar test reagents

• Chronic infectious disease, system or organ disorder or other medical condition that would place patient at undue risk by study participation