NCT02131324

DFD06 Cream vs Clobetasol Propionate Cream, 0.05% Hypothalamic- Pituitary-Adrenal (HPA) Axis Suppression Study in Patients With Moderate to Severe Plaque Psoriasis

A Randomized, Open Label, Study to Assess the Potential for Adrenal Suppression and Systemic Drug Absorption With DFD-06 Cream Versus Clobetasol Propionate Cream, 0.05% in Subjects With Moderate to Severe Plaque Psoriasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Promius Pharma, LLC · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the potential of DFD06 cream to suppress the HPA (hypothalamic-pituitary-adrenal) axis as compared to clobetasol propionate cream, 0.05% cream when applied twice daily for 15 days.

Detailed description

This was a 15-day, randomized, multicenter, comparator-controlled, open-label study. Approximately 50 subjects with moderate to severe plaque psoriasis were to be randomized to treatment with DFD-06 Cream or clobetasol propionate cream in a 1:1 ratio. Study products were applied twice daily for 15 days to all affected areas on the body excluding face, scalp, groin, axillae, and other intertriginous areas. Subject visits were scheduled at Screening, Baseline (Day 1), Day 8, Day 15, and Day 43 (if needed to confirm recovery). Clinical determinations of disease severity were conducted using the Investigator's Global Assessment (IGA) for overall severity at each visit.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	DFD06 Cream
DRUG	Clobetasol Propionate Cream 0.05%

Timeline

• Start date: 2014-05-08
• Primary completion: 2016-04-01
• Completion: 2016-08-11
• First posted: 2014-05-06
• Last updated: 2018-05-18
• Results posted: 2018-04-18

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study