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

October 4, 2021 updated by: BioMimetix JV, LLC

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
139

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
7-28 days
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
7-28 days
Efficacy of BMX-010 against Placebo on Atopic Dermatitis and Psoriasis Lesions
Time Frame: 7-28 days
Assessment of efficacy
7-28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Peak Plasma Concentrations (Cmax) for BMX-010
Time Frame: 8 days
8 days
Area Under the Plasma Concentration Versus Time Curve (AUC) for BMX-010
Time Frame: 8 days
8 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BioMimetix JV, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 2, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 24, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 24, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 22, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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