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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-02

Study Completion Date

2021-07-24

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Psoriasis Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double-blind

Study Groups

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BMX-010 0.03%

200 subjects will receive BMX-010 0.03% twice daily for 7-28 days applied to psoriasis or atopic dermatitis lesions.

Group Type EXPERIMENTAL

BMX-010

Intervention Type DRUG

Safety and efficacy of BMX-010 in topical treatment of psoriasis and/or atopic dermatitis.

Placebo

100 subjects will receive placebo twice daily for 7-28 days applied to psoriasis or atopic dermatitis lesions.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Topical administration of placebo in patients with psoriasis and/or atopic dermatitis.

Interventions

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BMX-010

Safety and efficacy of BMX-010 in topical treatment of psoriasis and/or atopic dermatitis.

Intervention Type DRUG

Placebo

Topical administration of placebo in patients with psoriasis and/or atopic dermatitis.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No