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

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.

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