NCT03381625

Topical Application of BMX-010 in Subjects With Atopic Dermatitis and Plaque Psoriasis

A Randomized, Placebo-Controlled, Dose-Escalation Trial to Evaluate the Safety, Clinical Effects, and Systemic Exposure of a Topical Application of BMX-010 in Subjects With Atopic Dermatitis and Plaque Psoriasis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: BioMimetix JV, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, placebo-controlled Phase 2 trial consisting of up to 300 subjects with either psoriasis or atopic dermatitis. In this trial BMX-010 will be topically applied twice daily for up to 28 days.

Detailed description

This is a Phase 2, randomized, multicenter, placebo-controlled study sponsored by BioMimetix JV, LLC (BMX). It is a double-blind parallel cohort study designed to determine the safety and efficacy of BMX-010 (0.03%) relative to Placebo in subjects with atopic dermatitis and psoriasis. Subjects will be queried regarding adverse events (AEs) and concomitant medication usage.

Conditions

• Psoriasis
• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	BMX-010	Safety and efficacy of BMX-010 in topical treatment of psoriasis and/or atopic dermatitis.
DRUG	Placebo	Topical administration of placebo in patients with psoriasis and/or atopic dermatitis.

Timeline

• Start date: 2018-01-02
• Primary completion: 2021-07-24
• Completion: 2021-07-24
• First posted: 2017-12-22
• Last updated: 2021-10-05

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study