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

Completed · Phase 2 · Has a placebo group

Conditions studied: Psoriasis, Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT03381625

Run by

BioMimetix JV, LLC

People needed

139

Starts

2018-01-02

Expected to finish

2021-07-24

Last updated by the study team

2021-10-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Encino Research Center — Encino, California, United States
• Apex Dermatology — Denver, Colorado, United States
• Colorado Skin Care — Englewood, Colorado, United States
• AboutSkin Dermatology & DermSurgery — Greenwood Village, Colorado, United States
• Ciocca Dermatology — Miami, Florida, United States
• Dawes Fretzin Dermatology Group — Indianapolis, Indiana, United States
• Juva Skin & Laser Center — New York, New York, United States
• Coastal Carolina Research Center — Mt. Pleasant, South Carolina, United States
• Dermatology Associates of Nashville — Knoxville, Tennessee, United States
• Presicion Research Institute — Houston, Texas, United States

Full record on ClinicalTrials.gov

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