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

Clinical Trial ID: NCT03381625

Description

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.


Criteria

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

  • Start Date

    2018-01-02

  • Last Updated

    2019-04-03

  • Sponsor

    BioMimetix JV, LLC

  • Condition Name

    Atopic Dermatitis

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