Atopic Dermatitis, Psoriasis
Conditions
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.
Interventions
DRUGBMX-010
Safety and efficacy of BMX-010 in topical treatment of psoriasis and/or atopic dermatitis.
DRUGPlacebo
Topical administration of placebo in patients with psoriasis and/or atopic dermatitis.
Sponsors
BioMimetix JV, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systemic Adverse Events Caused by BMX-010 on Atopic Dermatitis Lesions | 7-28 days | Assessment of adverse events occurring following topical administration of BMX-010 to atopic dermatitis lesions |
| Systemic Adverse Events Caused by BMX-010 on Psoriasis Lesions | 7-28 days | Assessment of adverse events occurring following topical administration of BMX-010 to psoriasis lesions |
| Efficacy of BMX-010 against Placebo on Atopic Dermatitis and Psoriasis Lesions | 7-28 days | Assessment of efficacy |
Secondary
| Measure | Time frame |
|---|---|
| Peak Plasma Concentrations (Cmax) for BMX-010 | 8 days |
| Area Under the Plasma Concentration Versus Time Curve (AUC) for BMX-010 | 8 days |
Countries
United States
Outcome results
None listed