Topical Application of BMX-010 in Subjects With Atopic Dermatitis and Plaque Psoriasis
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
1 other identifier
interventional
139
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2018
Typical duration for phase_2
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2016
CompletedFirst Posted
Study publicly available on registry
December 22, 2017
CompletedStudy Start
First participant enrolled
January 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 24, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 24, 2021
CompletedOctober 5, 2021
October 1, 2021
3.6 years
August 18, 2016
October 4, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Systemic Adverse Events Caused by BMX-010 on Atopic Dermatitis Lesions
Assessment of adverse events occurring following topical administration of BMX-010 to atopic dermatitis lesions
7-28 days
Systemic Adverse Events Caused by BMX-010 on Psoriasis Lesions
Assessment of adverse events occurring following topical administration of BMX-010 to psoriasis lesions
7-28 days
Efficacy of BMX-010 against Placebo on Atopic Dermatitis and Psoriasis Lesions
Assessment of efficacy
7-28 days
Secondary Outcomes (2)
Peak Plasma Concentrations (Cmax) for BMX-010
8 days
Area Under the Plasma Concentration Versus Time Curve (AUC) for BMX-010
8 days
Study Arms (2)
BMX-010 0.03%
EXPERIMENTAL200 subjects will receive BMX-010 0.03% twice daily for 7-28 days applied to psoriasis or atopic dermatitis lesions.
Placebo
PLACEBO COMPARATOR100 subjects will receive placebo twice daily for 7-28 days applied to psoriasis or atopic dermatitis lesions.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Encino Research Center
Encino, California, 91436, United States
Apex Dermatology
Denver, Colorado, 80230, United States
Colorado Skin Care
Englewood, Colorado, 80113, United States
AboutSkin Dermatology & DermSurgery
Greenwood Village, Colorado, 80111, United States
Ciocca Dermatology
Miami, Florida, 33173, United States
Dawes Fretzin Dermatology Group
Indianapolis, Indiana, 46256, United States
Juva Skin & Laser Center
New York, New York, 10022, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
Dermatology Associates of Nashville
Knoxville, Tennessee, 37917, United States
Presicion Research Institute
Houston, Texas, 77029, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double-blind
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2016
First Posted
December 22, 2017
Study Start
January 2, 2018
Primary Completion
July 24, 2021
Study Completion
July 24, 2021
Last Updated
October 5, 2021
Record last verified: 2021-10