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

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.

Study Overview

• Status: Completed
• Conditions: Psoriasis; Atopic Dermatitis
• Intervention / Treatment: Drug: BMX-010; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 139
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Encino, California, United States, 91436
      • Encino Research Center
  • Colorado
    • Denver, Colorado, United States, 80230
      • Apex Dermatology
    • Englewood, Colorado, United States, 80113
      • Colorado Skin Care
    • Greenwood Village, Colorado, United States, 80111
      • AboutSkin Dermatology & DermSurgery
  • Florida
    • Miami, Florida, United States, 33173
      • Ciocca Dermatology
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Dawes Fretzin Dermatology Group
  • New York
    • New York, New York, United States, 10022
      • JUVA Skin & Laser Center
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Coastal Carolina Research Center
  • Tennessee
    • Knoxville, Tennessee, United States, 37917
      • Dermatology Associates of Nashville
  • Texas
    • Houston, Texas, United States, 77029
      • Presicion Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: BioMimetix JV, LLC

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2018
• Primary Completion (Actual): July 24, 2021
• Study Completion (Actual): July 24, 2021

Study Registration Dates

• First Submitted: August 18, 2016
• First Submitted That Met QC Criteria: December 18, 2017
• First Posted (Actual): December 22, 2017

Study Record Updates

• Last Update Posted (Actual): October 5, 2021
• Last Update Submitted That Met QC Criteria: October 4, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Skin Diseases, Papulosquamous; Hypersensitivity; Skin Diseases, Eczematous; Psoriasis; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: BMX-DERM-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No