Psoriasis Clinical Trial
Topical Application of BMX-010 in Subjects With Atopic Dermatitis and Plaque Psoriasis
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.
Full 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.
Eligibility 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
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There are 10 Locations for this study
Encino California, 91436, United States
Denver Colorado, 80230, United States
Englewood Colorado, 80113, United States
Greenwood Village Colorado, 80111, United States
Miami Florida, 33173, United States
Indianapolis Indiana, 46256, United States
New York New York, 10022, United States
Mount Pleasant South Carolina, 29464, United States
Knoxville Tennessee, 37917, United States
Houston Texas, 77029, United States
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