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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMX-010 0.03% | Experimental | 200 subjects will receive BMX-010 0.03% twice daily for 7-28 days applied to psoriasis or atopic dermatitis lesions. |
|
| Placebo | Placebo Comparator | 100 subjects will receive placebo twice daily for 7-28 days applied to psoriasis or atopic dermatitis lesions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMX-010 | Drug | Safety and efficacy of BMX-010 in topical treatment of psoriasis and/or atopic dermatitis. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systemic Adverse Events Caused by BMX-010 on Atopic Dermatitis Lesions | Assessment of adverse events occurring following topical administration of BMX-010 to atopic dermatitis lesions | 7-28 days |
| Systemic Adverse Events Caused by BMX-010 on Psoriasis Lesions | Assessment of adverse events occurring following topical administration of BMX-010 to psoriasis lesions | 7-28 days |
| Efficacy of BMX-010 against Placebo on Atopic Dermatitis and Psoriasis Lesions | Assessment of efficacy | 7-28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentrations (Cmax) for BMX-010 | 8 days | |
| Area Under the Plasma Concentration Versus Time Curve (AUC) for BMX-010 | 8 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Encino Research Center | Encino | California | 91436 | United States | ||
| Apex Dermatology |
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Double-blind
| Placebo | Drug | Topical administration of placebo in patients with psoriasis and/or atopic dermatitis. |
|
| Denver |
| Colorado |
| 80230 |
| United States |
| Colorado Skin Care | Englewood | Colorado | 80113 | United States |
| AboutSkin Dermatology & DermSurgery | Greenwood Village | Colorado | 80111 | United States |
| Ciocca Dermatology | Miami | Florida | 33173 | United States |
| Dawes Fretzin Dermatology Group | Indianapolis | Indiana | 46256 | United States |
| Juva Skin & Laser Center | New York | New York | 10022 | United States |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | United States |
| Dermatology Associates of Nashville | Knoxville | Tennessee | 37917 | United States |
| Presicion Research Institute | Houston | Texas | 77029 | United States |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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