NCT01229098

Effect of LEO 80185 Gel on the HPA Axis and Calcium Metabolism in Subjects With Extensive Psoriasis Vulgaris

A Phase 2 Maximal Use Systemic Exposure Study Evaluating the Safety and Efficacy of Calcipotriol 50 mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Gel Applied Once Daily in Subjects With Extensive Psoriasis Vulgaris on the Scalp and Non-scalp Regions of the Body (Trunk and/or Limbs)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effect of once daily use of LEO 80185 gel on the hypothalamic-pituitary-adrenal (HPA) axis and calcium metabolism in subjects with extensive psoriasis vulgaris.

Conditions

• Psoriasis Vulgaris

Interventions

Type	Name	Description
DRUG	LEO 80185 (Xamiol® gel/Taclonex® Scalp topical suspension)	LEO 80185 (Taclonex® Scalp topical suspension/Xamiol® gel) Topical suspension applied once daily for up to 8 weeks

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-09-01
• Completion: 2011-10-01
• First posted: 2010-10-27
• Last updated: 2025-02-24

Locations

10 sites across 1 country: Canada