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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Psoriasis, Atopic Dermatitis

Intervention / Treatment
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* Drug: BMX-010
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMX-010 0.03%<br>200 subjects will receive BMX-010 0.03% twice daily for 7-28 days applied to psoriasis or atopic dermatitis lesions. | Drug: BMX-010<br>* Safety and efficacy of BMX-010 in topical treatment of psoriasis and/or atopic dermatitis.<br>|
| Placebo Comparator: Placebo<br>100 subjects will receive placebo twice daily for 7-28 days applied to psoriasis or atopic dermatitis lesions. | Drug: Placebo<br>* Topical administration of placebo in patients with psoriasis and/or atopic dermatitis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 7-28 days | 
| Efficacy of BMX-010 against Placebo on Atopic Dermatitis and Psoriasis Lesions | Assessment of efficacy | 7-28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentrations (Cmax) for BMX-010 |  | 8 days | 
| Area Under the Plasma Concentration Versus Time Curve (AUC) for BMX-010 |  | 8 days |