Topical Application of BMX-010 in Subjects With Atopic Dermatitis and Plaque Psoriasis
Status: | Recruiting |
---|---|
Conditions: | Psoriasis, Dermatology, Dermatology, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/6/2019 |
Start Date: | January 2, 2018 |
End Date: | December 2019 |
Contact: | Sara Penchev |
Email: | contact@bmxpharma.com |
Phone: | 720-613-4872 |
A Randomized, Placebo-Controlled, Dose-Escalation Trial to Evaluate the Safety, Clinical Effects, and Systemic Exposure of a Topical Application of BMX-010 in Subjects With Atopic Dermatitis and Plaque Psoriasis
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.
either psoriasis or atopic dermatitis. In this trial BMX-010 will be topically applied twice
daily for up to 28 days.
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.
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.
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
We found this trial at
10
sites
Indianapolis, Indiana 46256
Principal Investigator: Kenneth Dawes, MD
Phone: 317-621-7790
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3701 South Clarkson Street
Englewood, Colorado 80113
Englewood, Colorado 80113
Principal Investigator: Kimberly C Stone, MD
Phone: 303-740-4883
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Greenwood Village, Colorado
Principal Investigator: Joel Cohen, MD
Phone: 303-756-7546
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Houston, Texas 77029
Principal Investigator: Julian Gonzalez, MD
Phone: 713-453-8328
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Knoxville, Tennessee 37917
Principal Investigator: Edward Primka, MD
Phone: 865-524-2547
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Miami, Florida 33173
Principal Investigator: Giovanna Ciocca, MD
Phone: 305-273-7998
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Mount Pleasant, South Carolina 29464
Principal Investigator: Cynthia Strout, MD
Phone: 843-856-3784
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New York, New York 10022
Principal Investigator: Bruce Katz, MD
Phone: 212-688-5882
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