RosaceaPhase 2NCT03756389

Evaluation of Topical Application of BMX-010 in Subjects With Rosacea

A Phase 2 study testing BMX-010 in people with Rosacea, run by BioMimetix JV, LLC at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This is an exploratory Phase 2 trial of BMX-010 in patients with Rosacea which will be conducted in two parts. Up to 210 subjects with Rosacea will be enrolled. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rosacea
What is being tested?: BMX-010
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: 20 Feb 2019to 13 Feb 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, at least 18 years of age;
A clinical diagnosis of mild to severe facial rosacea;
Screening and Baseline IGA score > 2 (greater than or equal to 2);
A minimum Clinician Erythema Assessment (CEA) score of 2 at Screening and at Baseline Visits (prior to the investigational product application);
Willing to refrain from using any topical or systemic treatments for inflammatory skin disease, other than the investigational product;
Candidate for topical treatment of Rosacea;

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If a cleanser, moisturizer or sunscreen is needed during the study, Subjects must be willing to use only allowed cleansers, moisturizers, sunscreens, or moisturizer/sunscreen combination products. If the subject wears makeup they must agree to use non-comedogenic makeup;
Females of child-bearing potential must have a negative urine pregnancy test within 48 hours prior to the first drug administration;
Females of child-bearing potential must be willing to use 2 methods of contraception deemed adequate by the investigator (for example, oral contraceptive pills plus a barrier method) through the trial and for 1 month thereafter to be eligible for, and continue participation in, the study;
Ability to complete the study in compliance with the protocol, including agreement in writing to apply study product only to the assigned areas; and
Ability to understand and provide written informed consent.

Who cannot join

Any dermatological conditions on the face that could interfere with clinical evaluations;
Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive;
Presence of beard or excessive facial hair at Screening which would interfere with the study treatments or study assessments and refusal to remove for duration of study;
Subjects with any underlying disease that the Investigator deems uncontrolled, and poses a concern for the subject's safety while participating in the study;
Concomitant skin disease that could confound clinical evaluations or increase risk to the subject;
Use of medicated make-up (including anti-aging make-up) throughout the study;

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Use during the study of 1) systemic steroids, 2) topical retinoids to the face, 3) antibiotics known to impact rosacea, 4) immunosuppressive agents, or immunomodulators;
Facial use of 1) topical steroids, 2) topical anti-inflammatory agents, 3) topical antimycotics, 4) any topical rosacea treatments or 4) topical antibiotics;
Use of medicated cleansers on the face (throughout the study);
Use of topical astringents or abrasives, medical topical preparations (prescription and OTC products) within 2 days prior to Baseline and throughout the study;
Systemic or skin infection requiring antimicrobial therapy;
Systemic chemotherapy or radiotherapy within 4 weeks of the Baseline Visit;
Immunocompromise of any cause, known human immunodeficiency virus infection, or acquired immunodeficiency syndrome;
Pregnancy, planned pregnancy, lactation, or inadequate contraception as judged by the investigator;
Active drug or alcohol dependence;
Significant acute or chronic medical, neurological, or psychiatric illness that, in the judgment of the investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study;
Previous clinical trial participation for the indication being treated in this protocol.

Trial locations and contacts

1 site in 1 country.

United States1 site

Colorado Skin Care
Englewood, Colorado, 80113

Other trials in United States

About this study

Official title: An Exploratory Trial to Evaluate the Clinical Effectiveness of a Topical Application of BMX-010 in Subjects With Rosacea

This is an exploratory Phase 2 trial of BMX-010 in patients with Rosacea which will be conducted in two parts. Up to 210 subjects with Rosacea will be enrolled.

Read the detailed description

Part A is designed to confirm the optimal formulation, strength, and dosing frequency of the study drug. Up to 60 subjects will be enrolled in this part.

Part B is designed to be a randomized, double-blind trial studying the optimal formulation, strength, and dosing frequency of BMX-010 as determined in Part A, compared to Placebo. Up to 150 subjects will be enrolled in this part.

In both parts, adult subjects with Rosacea will be enrolled.

Conditions: Rosacea
Being tested: BMX-010
Medical subject headings: Rosacea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BMX-010Drug
Safety and efficacy of BMX-010 in topical treatment of rosacea.

Study groups in NCT03756389
Study group	Role	What they receive
BMX-010 0.03%	Experimental	Approximately 30 subjects will receive BMX-010 0.03% for 7-28 days to be applied topically to Rosacea of the face. Receives: Drug: BMX-010
BMX-010 0.1%	Experimental	Approximately 30 subjects will receive BMX-010 0.1% for 7-28 days to be applied topically to Rosacea of the face. Receives: Drug: BMX-010

What is being measured

The primary outcome is the main question the study is designed to answer.

Investigator Global Assessment (IGA) Grade: Clinically Meaningful Rosacea Treatment Success Rate
The percentage of subjects will be reported that experience a clinically meaningful treatment success, which is defined as a 2-point reduction in Investigator Global Assessment (IGA) grade from the baseline assessment prior to treatment to the final assessment two weeks after dosing ends (Day 43).
Measured: 43 days
Clinical Erythema Assessment (CEA): Clinically Meaningful Erythema Reduction Rate
Assessed by number of participants with at least a 2-point reduction in Clinical Erythema Assessment (CEA) grade from the baseline score prior to treatment to a final assessment two weeks after dosing ends (Day 43).
Measured: 43 days
Investigator Global Assessment (IGA) Grade: Rosacea Severity Change Over Treatment Period
The Investigator Global Assessment (IGA) grade, which will be assessed weekly, is a clinical assessment of disease severity. Scores range from 0 (clear) - 4 (severe). The change in IGA score from Baseline to 28 days of treatment will be reported.
Measured: 28 days
Clinical Erythema Assessment (CEA): Erythema Severity Change Over Treatment Period
The Clinical Erythema Assessment (CEA) grade will be assessed weekly. Grades range from 0 = clear/no erythema to 4 = severe/fiery red erythema. The change in CEA score from Baseline to 28 days of treatment will be reported.
Measured: 28 days
Investigator Global Assessment (IGA) Grade: Clinically Meaningful Rosacea Reduction During Treatment
The percentage of subjects will be reported that experience a clinically meaningful rosacea reduction, which is defined as a 2-point reduction in Investigator Global Assessment (IGA) grade over the treatment period of 28 days.
Measured: 28 days

Secondary outcomes (2)

Clinical Photography Documenting Rosacea Symptoms in Patients Treated With BMX-010
If consented by the patient, photos will be taken at each study visit. The number of patients photographed will be reported.
Measured: 43 days
Change in Number of Inflammatory Papules/Pustules From Baseline to 43 Day Follow-up.
Inflammatory lesions will be counted at each study visit. The mean percent change in inflammatory papules/pustules counts from baseline to the final (day 43) follow-up will be reported.
Measured: 43 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Feb 201913 Feb 2023

First posted28 Nov 2018
Study start20 Feb 2019
Primary completion2 Jul 2019
Study completion13 Feb 2023

Why it stopped: Re-formulation of study product needed.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for RosaceaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03756389
Sponsor's protocol ID: BMX-DERM-202
Status last verified: Oct 2026
First submitted: 15 Nov 2018
Last updated: 5 Nov 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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IBS (Irritable Bowel Syndrome), Rosacea
Enrolling by invitation
Vbeam Pro Pulse Dye Laser for the Treatment of Vascular Conditions
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RecruitingPhase 2
A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)
Papulopustular Rosacea
Recruiting
Dermocosmetic Treatment for Facial Redness in Rosacea With or Without Laser Therapy
Rosacea, Erythematotelangiectatic, Rosacea Subtype 1 (Erythematotelangiectatic)
RecruitingObservational study
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All Rosacea trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Exploratory Trial to Evaluate the Clinical Effectiveness of a Topical Application of BMX-010 in Subjects With Rosacea
ClinicalTrials.gov ID: NCT03756389
Acronym / sponsor ID: BMX-DERM-202
Conditions: Rosacea
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Re-formulation of study product needed.
Enrolment: 6 participants (actual)
Lead sponsor: BioMimetix JV, LLCIndustry (pharma, biotech, devices)
Study start: 20 Feb 2019 (actual)
Primary completion: 2 Jul 2019 (actual)
Study completion: 13 Feb 2023 (actual)
First posted: 28 Nov 2018 (actual)
Results: Posted 5 Nov 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is an exploratory Phase 2 trial of BMX-010 in patients with Rosacea which will be conducted in two parts. Up to 210 subjects with Rosacea will be enrolled.

Detailed description

Part A is designed to confirm the optimal formulation, strength, and dosing frequency of the study drug. Up to 60 subjects will be enrolled in this part.

In both parts, adult subjects with Rosacea will be enrolled.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
BMX-010 0.03%	Experimental	Drug: BMX-010Approximately 30 subjects will receive BMX-010 0.03% for 7-28 days to be applied topically to Rosacea of the face.
BMX-010 0.1%	Experimental	Drug: BMX-010Approximately 30 subjects will receive BMX-010 0.1% for 7-28 days to be applied topically to Rosacea of the face.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Male or female, at least 18 years of age;
A clinical diagnosis of mild to severe facial rosacea;
Screening and Baseline IGA score > 2 (greater than or equal to 2);
A minimum Clinician Erythema Assessment (CEA) score of 2 at Screening and at Baseline Visits (prior to the investigational product application);
Willing to refrain from using any topical or systemic treatments for inflammatory skin disease, other than the investigational product;

Key exclusion criteria (17 listed)

Any dermatological conditions on the face that could interfere with clinical evaluations;
Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive;
Presence of beard or excessive facial hair at Screening which would interfere with the study treatments or study assessments and refusal to remove for duration of study;
Subjects with any underlying disease that the Investigator deems uncontrolled, and poses a concern for the subject's safety while participating in the study;
Concomitant skin disease that could confound clinical evaluations or increase risk to the subject;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BMX-010Safety and efficacy of BMX-010 in topical treatment of rosacea.	Drug	BMX-010 0.03%, BMX-010 0.1%

Primary outcome

Investigator Global Assessment (IGA) Grade: Clinically Meaningful Rosacea Treatment Success Rate
Time frame: 43 days
The percentage of subjects will be reported that experience a clinically meaningful treatment success, which is defined as a 2-point reduction in Investigator Global Assessment (IGA) grade from the baseline assessment prior to treatment to the final assessment two weeks after dosing ends (Day 43).
Clinical Erythema Assessment (CEA): Clinically Meaningful Erythema Reduction Rate
Time frame: 43 days
Assessed by number of participants with at least a 2-point reduction in Clinical Erythema Assessment (CEA) grade from the baseline score prior to treatment to a final assessment two weeks after dosing ends (Day 43).
Investigator Global Assessment (IGA) Grade: Rosacea Severity Change Over Treatment Period
Time frame: 28 days
The Investigator Global Assessment (IGA) grade, which will be assessed weekly, is a clinical assessment of disease severity. Scores range from 0 (clear) - 4 (severe). The change in IGA score from Baseline to 28 days of treatment will be reported.
Clinical Erythema Assessment (CEA): Erythema Severity Change Over Treatment Period
Time frame: 28 days
The Clinical Erythema Assessment (CEA) grade will be assessed weekly. Grades range from 0 = clear/no erythema to 4 = severe/fiery red erythema. The change in CEA score from Baseline to 28 days of treatment will be reported.
Investigator Global Assessment (IGA) Grade: Clinically Meaningful Rosacea Reduction During Treatment
Time frame: 28 days
The percentage of subjects will be reported that experience a clinically meaningful rosacea reduction, which is defined as a 2-point reduction in Investigator Global Assessment (IGA) grade over the treatment period of 28 days.

2 secondary outcomes

Clinical Photography Documenting Rosacea Symptoms in Patients Treated With BMX-010
Time frame: 43 days
Change in Number of Inflammatory Papules/Pustules From Baseline to 43 Day Follow-up.
Time frame: 43 days

Results and safety

Results posted to the registry on 5 Nov 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BMX-010 0.03% QD	6	6

Primary outcome: Investigator Global Assessment (IGA) Grade: Clinically Meaningful Rosacea Treatment Success Rate

Time frame: 43 days. Count of participants. Unit: Participants

Measure	BMX-010 0.03% n = 6
Value	3

Population analysed: This study followed only a single arm, and all subjects completed this assessment and were included in the analysis.

Primary outcome: Clinical Erythema Assessment (CEA): Clinically Meaningful Erythema Reduction Rate

Time frame: 43 days. Count of participants. Unit: Participants

Measure	BMX-010 0.03% n = 6
Value	1

Population analysed: This study followed only a single arm, and all subjects completed this assessment and were included in the analysis.

Primary outcome: Investigator Global Assessment (IGA) Grade: Rosacea Severity Change Over Treatment Period

Time frame: 28 days. Mean (Standard Deviation). Unit: change in IGA score

Measure	BMX-010 0.03% n = 6
Value	-1.17 (0.75)

Primary outcome: Clinical Erythema Assessment (CEA): Erythema Severity Change Over Treatment Period

Time frame: 28 days. Mean (Standard Deviation). Unit: change in CEA score

Measure	BMX-010 0.03% n = 6
Value	-1.17 (0.75)

Population analysed: This study followed only a single arm, and all subjects completed this assessment.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment until the end of follow-up. Patients were follow for up to 1 year.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BMX-010 0.03%	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Rosacea

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Enrolling by invitation
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BMX-010 in people with Rosacea, run by BioMimetix JV, LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Investigator Global Assessment (IGA) Grade: Clinically Meaningful Rosacea Treatment Success Rate (time frame: 43 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03756389.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.