Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years and Over|
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
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|BioMimetix JV, LLC|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||N/A|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Psoriasis, Atopic Dermatitis|
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.
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.
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.