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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
139
Encino Research Center
Encino, California, United States
Apex Dermatology
Denver, Colorado, United States
Colorado Skin Care
Englewood, Colorado, United States
Systemic Adverse Events Caused by BMX-010 on Atopic Dermatitis Lesions
Assessment of adverse events occurring following topical administration of BMX-010 to atopic dermatitis lesions
Time frame: 7-28 days
Systemic Adverse Events Caused by BMX-010 on Psoriasis Lesions
Assessment of adverse events occurring following topical administration of BMX-010 to psoriasis lesions
Time frame: 7-28 days
Efficacy of BMX-010 against Placebo on Atopic Dermatitis and Psoriasis Lesions
Assessment of efficacy
Time frame: 7-28 days
Peak Plasma Concentrations (Cmax) for BMX-010
Time frame: 8 days
Area Under the Plasma Concentration Versus Time Curve (AUC) for BMX-010
Time frame: 8 days
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