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

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ClinicalTrials.gov Identifier: NCT03381625
Recruitment Status : Recruiting
First Posted : December 22, 2017
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
BioMimetix JV, LLC

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.

Condition or disease Intervention/treatment Phase
Psoriasis Atopic Dermatitis Drug: BMX-010 Drug: Placebo Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Treatment
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
Actual Study Start Date : January 2, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Psoriasis

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

Placebo Comparator: Placebo
100 subjects will receive placebo twice daily for 7-28 days applied to psoriasis or atopic dermatitis lesions.
Drug: Placebo
Topical administration of placebo in patients with psoriasis and/or atopic dermatitis.




Primary Outcome Measures :
  1. Systemic Adverse Events Caused by BMX-010 on Atopic Dermatitis Lesions [ Time Frame: 7-28 days ]
    Assessment of adverse events occurring following topical administration of BMX-010 to atopic dermatitis lesions

  2. Systemic Adverse Events Caused by BMX-010 on Psoriasis Lesions [ Time Frame: 7-28 days ]
    Assessment of adverse events occurring following topical administration of BMX-010 to psoriasis lesions

  3. Efficacy of BMX-010 against Placebo on Atopic Dermatitis and Psoriasis Lesions [ Time Frame: 7-28 days ]
    Assessment of efficacy


Secondary Outcome Measures :
  1. Peak Plasma Concentrations (Cmax) for BMX-010 [ Time Frame: 8 days ]
  2. Area Under the Plasma Concentration Versus Time Curve (AUC) for BMX-010 [ Time Frame: 8 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03381625


Contacts
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Contact: Sara Penchev 720-613-4872 contact@bmxpharma.com

Locations
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United States, California
Encino Research Center Recruiting
Encino, California, United States, 91436
Contact: Sarah Emert         
Principal Investigator: Tooraj Raoof, MD         
United States, Colorado
Apex Dermatology Completed
Denver, Colorado, United States, 80230
Colorado Skin Care Recruiting
Englewood, Colorado, United States, 80113
Contact: Kathryn Adams    303-740-4883      
Principal Investigator: Kimberly C Stone, MD         
AboutSkin Dermatology & DermSurgery Recruiting
Greenwood Village, Colorado, United States, 80111
Contact: Kilee Moore    303-756-7546      
Principal Investigator: Joel Cohen, MD         
United States, Florida
Ciocca Dermatology Recruiting
Miami, Florida, United States, 33173
Contact: Victoria Diartt, NP    305-273-7998      
Principal Investigator: Giovanna Ciocca, MD         
United States, Indiana
Dawes Fretzin Dermatology Group Recruiting
Indianapolis, Indiana, United States, 46256
Contact: Laura Murphy    317-621-7790    LSuchy@ecommunity.com   
Principal Investigator: Kenneth Dawes, MD         
United States, New York
Juva Skin & Laser Center Recruiting
New York, New York, United States, 10022
Contact: Valerija Misev    212-688-5882      
Principal Investigator: Bruce Katz, MD         
United States, South Carolina
Coastal Carolina Research Center Recruiting
Mount Pleasant, South Carolina, United States, 29464
Contact: Becky Empric    843-856-3784      
Principal Investigator: Cynthia Strout, MD         
United States, Tennessee
Dermatology Associates of Nashville Recruiting
Knoxville, Tennessee, United States, 37917
Contact: Kim Hall    865-524-2547    khall@dermaknox.com   
Principal Investigator: Edward Primka, MD         
United States, Texas
Presicion Research Institute Recruiting
Houston, Texas, United States, 77029
Contact: Elizabeth Hernandez    713-453-8328    eliz@precisionri.com   
Principal Investigator: Julian Gonzalez, MD         
Sponsors and Collaborators
BioMimetix JV, LLC

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Responsible Party: BioMimetix JV, LLC
ClinicalTrials.gov Identifier: NCT03381625     History of Changes
Other Study ID Numbers: BMX-DERM-01
First Posted: December 22, 2017    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Psoriasis
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases, Papulosquamous
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases