NCT02527421

DFD01 Spray HPA Axis Suppression Study in Adolescent Patients With Moderate to Severe Plaque Psoriasis

A Randomized, Parallel Group, Open-Label, Multicenter Study to Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing With DFD-01 (Betamethasone Dipropionate) Spray, 0.05%

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Primus Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the potential of DFD-01 (betamethasone dipropionate) Spray, 0.05% to suppress the hypothalamic-pituitary-adrenal (HPA) axis.

Detailed description

To evaluate the potential of DFD-01 (betamethasone dipropionate) Spray, 0.05% to suppress the hypothalamic-pituitary-adrenal (HPA) axis when applied twice daily for 15 days or when applied twice daily for 29 days, in adolescent subjects with moderate to severe plaque psoriasis under maximal use conditions.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	DFD01 Spray	DFD-01 (betamethasone dipropionate) Spray, 0.05%

Timeline

• Start date: 2015-08-19
• Primary completion: 2019-03-30
• Completion: 2019-03-30
• First posted: 2015-08-19
• Last updated: 2024-03-07
• Results posted: 2021-10-21

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study