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

• Status: Completed
• Trial end date: 2021-07-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: BioMimetix JV, LLC

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