NCT04221906

Study to Evaluate the Safety and Antipsoriatic Efficacy of BOS-475 in a Psoriasis Plaque Test

A Phase Ib, Multi-Center, Randomized, Vehicle- and Comparator-Controlled Trial, Double-Blind for the Investigational Medicinal Products, Observer-Blind for the Comparators to Evaluate the Safety and Antipsoriatic Efficacy of BOS-475 in a Psoriasis Plaque Test

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Boston Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted to evaluate the safety of topical BOS-475 compared to topically applied comparator formulations and vehicle.

Detailed description

This is a three-center, randomized, placebo- and comparator-controlled, double-blind for the Investigational Medicinal Products (IMPs), observer-blind for the controls, intraindividual comparison of all 6 treatments.

Conditions

• Chronic Plaque Psoriasis

Interventions

Type	Name	Description
DRUG	BOS-475	topical cream
DRUG	Active ingredient-free vehicle cream	topical cream
DRUG	Daivonex cream (calcipotriol 0.005%)	topical cream
DRUG	Betnesol-V cream (betamethasone 0.1%)	topical cream

Timeline

• Start date: 2020-01-06
• Primary completion: 2020-03-06
• Completion: 2020-03-06
• First posted: 2020-01-09
• Last updated: 2020-11-18

Locations

3 sites across 1 country: Germany

Regulatory

• FDA-regulated drug study