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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03381625
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

BioMimetix JV, LLC
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis, Atopic Dermatitis
Additional Details

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.

Arms & Interventions

Arms

Experimental: 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.

Placebo Comparator: Placebo

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

Interventions

Drug: - BMX-010

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

Drug: - Placebo

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Encino Research Center, Encino, California

Status

Recruiting

Address

Encino Research Center

Encino, California, 91436

Site Contact

Sarah Emert

[email protected]

720-613-4872

Apex Dermatology, Denver, Colorado

Status

Completed

Address

Apex Dermatology

Denver, Colorado, 80230

Colorado Skin Care, Englewood, Colorado

Status

Recruiting

Address

Colorado Skin Care

Englewood, Colorado, 80113

Site Contact

Kathryn Adams

[email protected]

303-740-4883

AboutSkin Dermatology & DermSurgery, Greenwood Village, Colorado

Status

Recruiting

Address

AboutSkin Dermatology & DermSurgery

Greenwood Village, Colorado, 80111

Site Contact

Kilee Moore

[email protected]

303-756-7546

Ciocca Dermatology, Miami, Florida

Status

Recruiting

Address

Ciocca Dermatology

Miami, Florida, 33173

Site Contact

Victoria Diartt, NP

[email protected]

305-273-7998

Dawes Fretzin Dermatology Group, Indianapolis, Indiana

Status

Recruiting

Address

Dawes Fretzin Dermatology Group

Indianapolis, Indiana, 46256

Site Contact

Laura Murphy

[email protected]

317-621-7790

Juva Skin & Laser Center, New York, New York

Status

Recruiting

Address

Juva Skin & Laser Center

New York, New York, 10022

Site Contact

Valerija Misev

[email protected]

212-688-5882

Coastal Carolina Research Center, Mount Pleasant, South Carolina

Status

Recruiting

Address

Coastal Carolina Research Center

Mount Pleasant, South Carolina, 29464

Site Contact

Becky Empric

[email protected]

843-856-3784

Dermatology Associates of Nashville, Knoxville, Tennessee

Status

Recruiting

Address

Dermatology Associates of Nashville

Knoxville, Tennessee, 37917

Site Contact

Kim Hall

[email protected]

865-524-2547

Presicion Research Institute, Houston, Texas

Status

Recruiting

Address

Presicion Research Institute

Houston, Texas, 77029

Site Contact

Elizabeth Hernandez

[email protected]

713-453-8328

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.