Topical Application of BMX-010 in Subjects With Atopic Dermatitis and Plaque Psoriasis
- Registration Number
- NCT03381625
- Lead Sponsor
- BioMimetix JV, LLC
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 139
- Diagnosis of either atopic dermatitis or psoriasis with mild to moderate lesions involving 1% - 25% of total body surface area
- Candidate for topical treatment of atopic dermatitis or psoriasis
- Negative pregnancy test for females of childbearing potential
- Systemic pharmacotherapy or phototherapy for treatment of atopic dermatitis or psoriasis
- Erythrodermic, guttate or generalized pustular psoriasis
- Treatment of systemic retinoids, corticosteroids or immunosuppressive agents within 4 weeks of baseline visit
- Treatment with high potency topical steroids, vitamin D analogs, keratolytics, coal tar, phototherapy, calcineurin inhibitors, or antihistamines within 2 weeks of baseline visit
- UV or Dead Sea therapy within 4 weeks of baseline visit
- Treatment with a biologic agent (monoclonal antibody) within 30 days or 5 times its circulating half-life (whichever is longer) prior to baseline visit
- Atopic dermatitis triggered by environmental allergen or irritant
- Contact dermatitis or drug-induced skin reactions
- Systemic or skin infection requiring antimicrobial therapy
- Systemic chemotherapy or radiotherapy within 4 weeks of baseline visit
- Immunocompromise of any cause
- Pregnancy, lactation or inadequate contraception
- Active drug or alcohol dependence
- Significant acute or chronic medical, neurological or psychiatric illness that would compromise subject's safety
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BMX-010 0.03% BMX-010 200 subjects will receive BMX-010 0.03% twice daily for 7-28 days applied to psoriasis or atopic dermatitis lesions. Placebo Placebo 100 subjects will receive placebo twice daily for 7-28 days applied to psoriasis or atopic dermatitis lesions.
- Primary Outcome Measures
Name Time Method Systemic Adverse Events Caused by BMX-010 on Atopic Dermatitis Lesions 7-28 days Assessment of adverse events occurring following topical administration of BMX-010 to atopic dermatitis lesions
Systemic Adverse Events Caused by BMX-010 on Psoriasis Lesions 7-28 days Assessment of adverse events occurring following topical administration of BMX-010 to psoriasis lesions
Efficacy of BMX-010 against Placebo on Atopic Dermatitis and Psoriasis Lesions 7-28 days Assessment of efficacy
- Secondary Outcome Measures
Name Time Method Area Under the Plasma Concentration Versus Time Curve (AUC) for BMX-010 8 days Peak Plasma Concentrations (Cmax) for BMX-010 8 days
Trial Locations
- Locations (10)
Encino Research Center
🇺🇸Encino, California, United States
AboutSkin Dermatology & DermSurgery
🇺🇸Greenwood Village, Colorado, United States
Apex Dermatology
🇺🇸Denver, Colorado, United States
Ciocca Dermatology
🇺🇸Miami, Florida, United States
Dawes Fretzin Dermatology Group
🇺🇸Indianapolis, Indiana, United States
Coastal Carolina Research Center
🇺🇸Mount Pleasant, South Carolina, United States
Juva Skin & Laser Center
🇺🇸New York, New York, United States
Dermatology Associates of Nashville
🇺🇸Knoxville, Tennessee, United States
Presicion Research Institute
🇺🇸Houston, Texas, United States
Colorado Skin Care
🇺🇸Englewood, Colorado, United States