Back to resultsTopical Application of BMX-010 in Subjects With Atopic Dermatitis and Plaque Psoriasis
Primary Purpose
Psoriasis, Atopic Dermatitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BMX-010
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility 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
Sites / Locations
- Encino Research Center
- Apex Dermatology
- Colorado Skin Care
- AboutSkin Dermatology & DermSurgery
- Ciocca Dermatology
- Dawes Fretzin Dermatology Group
- Juva Skin & Laser Center
- Coastal Carolina Research Center
- Dermatology Associates of Nashville
- Presicion Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BMX-010 0.03%
Placebo
Arm Description
200 subjects will receive BMX-010 0.03% twice daily for 7-28 days applied to psoriasis or atopic dermatitis lesions.
100 subjects will receive placebo twice daily for 7-28 days applied to psoriasis or atopic dermatitis lesions.
Outcomes
Primary Outcome Measures
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
Systemic Adverse Events Caused by BMX-010 on Psoriasis Lesions
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
Assessment of efficacy
Secondary Outcome Measures
Peak Plasma Concentrations (Cmax) for BMX-010
Area Under the Plasma Concentration Versus Time Curve (AUC) for BMX-010
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03381625
Brief Title
Topical Application of BMX-010 in Subjects With Atopic Dermatitis and Plaque Psoriasis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
July 24, 2021 (Actual)
Study Completion Date
July 24, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioMimetix JV, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Atopic Dermatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
139 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BMX-010 0.03%
Arm Type
Experimental
Arm Description
200 subjects will receive BMX-010 0.03% twice daily for 7-28 days applied to psoriasis or atopic dermatitis lesions.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
100 subjects will receive placebo twice daily for 7-28 days applied to psoriasis or atopic dermatitis lesions.
Intervention Type
Drug
Intervention Name(s)
BMX-010
Intervention Description
Safety and efficacy of BMX-010 in topical treatment of psoriasis and/or atopic dermatitis.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Topical administration of placebo in patients with psoriasis and/or atopic dermatitis.
Primary Outcome Measure Information:
Title
Systemic Adverse Events Caused by BMX-010 on Atopic Dermatitis Lesions
Description
Assessment of adverse events occurring following topical administration of BMX-010 to atopic dermatitis lesions
Time Frame
7-28 days
Title
Systemic Adverse Events Caused by BMX-010 on Psoriasis Lesions
Description
Assessment of adverse events occurring following topical administration of BMX-010 to psoriasis lesions
Time Frame
7-28 days
Title
Efficacy of BMX-010 against Placebo on Atopic Dermatitis and Psoriasis Lesions
Description
Assessment of efficacy
Time Frame
7-28 days
Secondary Outcome Measure Information:
Title
Peak Plasma Concentrations (Cmax) for BMX-010
Time Frame
8 days
Title
Area Under the Plasma Concentration Versus Time Curve (AUC) for BMX-010
Time Frame
8 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Encino Research Center
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Apex Dermatology
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Colorado Skin Care
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
AboutSkin Dermatology & DermSurgery
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Facility Name
Ciocca Dermatology
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Dawes Fretzin Dermatology Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Juva Skin & Laser Center
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Dermatology Associates of Nashville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37917
Country
United States
Facility Name
Presicion Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77029
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Topical Application of BMX-010 in Subjects With Atopic Dermatitis and Plaque Psoriasis
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