NCT02340169

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

An Open Label, Safety Study to Assess the Potential for Adrenal Suppression and Pharmacokinetics Following Maximal Use Treatment With Topicort® (Desoximetasone) Topical Spray, 0.25% in Pediatric Patients With Plaque Psoriasis.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

An open label, post marketing safety study to assess the potential of a TOPICORT® (desoximetasone) Topical Spray, 0.25% to suppress HPA axis function following twice daily dosing for 28 days.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	Topicort® (desoximetasone) Topical Spray, 0.25%	Topicort® (desoximetasone) Topical Spray, 0.25% applied to affected areas twice a day for 28 days

Timeline

• Start date: 2015-01-23
• Primary completion: 2019-11-22
• Completion: 2021-11-22
• First posted: 2015-01-16
• Last updated: 2023-03-28
• Results posted: 2023-03-28

Locations

1 site across 1 country: United States