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.

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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.

View Eligibility Criteria

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

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

139

Study ID:

NCT03381625

Recruitment Status:

Completed

Sponsor:

BioMimetix JV, LLC

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There are 10 Locations for this study

See Locations Near You

Encino Research Center
Encino California, 91436, United States
Apex Dermatology
Denver Colorado, 80230, United States
Colorado Skin Care
Englewood Colorado, 80113, United States
AboutSkin Dermatology & DermSurgery
Greenwood Village Colorado, 80111, United States
Ciocca Dermatology
Miami Florida, 33173, United States
Dawes Fretzin Dermatology Group
Indianapolis Indiana, 46256, United States
Juva Skin & Laser Center
New York New York, 10022, United States
Coastal Carolina Research Center
Mount Pleasant South Carolina, 29464, United States
Dermatology Associates of Nashville
Knoxville Tennessee, 37917, United States
Presicion Research Institute
Houston Texas, 77029, United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

139

Study ID:

NCT03381625

Recruitment Status:

Completed

Sponsor:


BioMimetix JV, LLC

How clear is this clinincal trial information?

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