Status:
COMPLETED
Topical Application of BMX-010 in Subjects With Atopic Dermatitis and Plaque Psoriasis
Lead Sponsor:
BioMimetix JV, LLC
Conditions:
Psoriasis
Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 t...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 24 2021
Estimated Enrollment :
139 Patients enrolled
Trial Details
Trial ID
NCT03381625
Start Date
January 2 2018
End Date
July 24 2021
Last Update
October 5 2021
Active Locations (10)
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1
Encino Research Center
Encino, California, United States, 91436
2
Apex Dermatology
Denver, Colorado, United States, 80230
3
Colorado Skin Care
Englewood, Colorado, United States, 80113
4
AboutSkin Dermatology & DermSurgery
Greenwood Village, Colorado, United States, 80111