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Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Topical Administration of BOS-475 in Healthy Subjects and Patients With Psoriasis

Psoriasis Clinical Trial

Official title:
A Phase I, Randomized, Vehicle-Controlled, Double-Blind (Sponsor Open) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Topical Administration of BOS-475 in Healthy Subjects and Patients With Psoriasis

Clinical Trial Summary

This study was conducted to evaluate the safety and tolerability of BOS-475 following single and repeat topical administration to healthy participants (Part A), and to evaluate the safety and tolerability of 42-day repeat topical administration of BOS-475 to participants with plaque psoriasis (Part B).

Clinical Trial Description

In Part A, healthy participants were randomized to receive a single dose application of BOS-475 or vehicle cream. Following a washout period, participants received 7 days of repeated dosing with BOS-475 or vehicle cream on the back, followed by 7 days of repeated dosing of BOS-475 or vehicle cream over the facial area (excluding eye lids and areas around the mouth). In Part B, participants with mild to moderate stable plaque psoriasis affecting up to 15% of their body surface area were randomized to receive 6 weeks of topical treatment of BOS-475 or vehicle cream. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03960450
Study type Interventional
Source Boston Pharmaceuticals
Contact
Status Completed
Phase Phase 1
Start date April 23, 2019
Completion date January 28, 2020
View Details
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