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
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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Indianapolis, Indiana 46256
Principal Investigator: Kenneth Dawes, MD
Phone: 317-621-7790
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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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