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

BioMimetix

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis; Psoriasis

Treatments: Drug: BMX-010; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03381625

BMX-DERM-01

Details and patient eligibility

About

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.

Enrollment: 139 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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139 participants in 2 patient groups, including a placebo group

BMX-010 0.03%

Experimental group

Description:

200 subjects will receive BMX-010 0.03% twice daily for 7-28 days applied to psoriasis or atopic dermatitis lesions.

Treatment:

Drug: BMX-010

Placebo

Placebo Comparator group

Description:

100 subjects will receive placebo twice daily for 7-28 days applied to psoriasis or atopic dermatitis lesions.

Treatment:

Drug: Placebo