NCT03837743

Safety and Efficacy Study of DUR-928 Topical Solution in Subjects With Plaque Psoriasis

A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Proof of Concept Comparison Study of the Safety and Efficacy of DUR-928 Topical Solution With Occlusion in Subjects With Mild to Moderate Plaque Psoriasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Durect · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase 2 study has been designed to determine and compare the safety, tolerability, and efficacy of DUR-928 topical solution with that of the vehicle topical solution when applied once daily for approximately four weeks in subjects with plaque psoriasis. Subjects will be instructed (randomly assigned) to apply DUR-928 solution to a target lesion on one arm and vehicle solution to a target lesion on the opposite arm once daily for up to four weeks. Subjects will occlude the treated areas for approximately two hours after each application.

Conditions

• Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	DUR-928 Topical Solution	Topical solution containing active drug
DRUG	Vehicle Topical Solution	Topical solution containing no active drug

Timeline

• Start date: 2019-02-21
• Primary completion: 2019-11-11
• Completion: 2020-05-20
• First posted: 2019-02-12
• Last updated: 2022-09-02
• Results posted: 2022-09-02

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study