Clinical trial NCT03381625: Topical Application of BMX-010 in Subjects With Atopic Dermatitis and Plaque Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis
Atopic Dermatitis
Lead sponsor: BioMimetix JV, LLC
Sponsor class: INDUSTRY
First posted: 2017-12-22
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 to 28 days.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Systemic Adverse Events Caused by BMX-010 on Atopic Dermatitis Lesions
timeFrame: 7-28 days
measure: Systemic Adverse Events Caused by BMX-010 on Psoriasis Lesions
timeFrame: 7-28 days
measure: Efficacy of BMX-010 against Placebo on Atopic Dermatitis and Psoriasis Lesions
timeFrame: 7-28 days
Secondary outcomes:
measure: Peak Plasma Concentrations (Cmax) for BMX-010
timeFrame: 8 days
measure: Area Under the Plasma Concentration Versus Time Curve (AUC) for BMX-010
timeFrame: 8 days
Other outcomes:
Locations:
city: Encino
country: United States
facility: Encino Research Center
state: California
city: Denver
country: United States
facility: Apex Dermatology
state: Colorado
city: Englewood
country: United States
facility: Colorado Skin Care
state: Colorado
city: Greenwood Village
country: United States
facility: AboutSkin Dermatology & DermSurgery
state: Colorado
city: Miami
country: United States
facility: Ciocca Dermatology
state: Florida
city: Indianapolis
country: United States
facility: Dawes Fretzin Dermatology Group
state: Indiana
city: New York
country: United States
facility: Juva Skin & Laser Center
state: New York
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Knoxville
country: United States
facility: Dermatology Associates of Nashville
state: Tennessee
city: Houston
country: United States
facility: Presicion Research Institute
state: Texas
Study officials:
References: