Acne VulgarisPhase 2NCT03752242

Evaluation of Topical Application of BMX-010 in Subjects With Acne Vulgaris.

A Phase 2 study testing BMX-010 0.3% in people with Acne Vulgaris, 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.

Official record

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Trial summary

This is an exploratory Phase 2 trial of BMX-010 in patients with Acne Vulgaris which will be conducted in two parts. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acne Vulgaris
What is being tested?: BMX-010 0.3%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 1 siteUnited States
Study dates: 3 Jan 2019to 31 Aug 2020
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 Acne Vulgaris; Subjects may also have acne at other body sites;
Screening and Baseline IGA score > 2 (greater than or equal to 2);
Willing to refrain from using any topical or systemic treatments for inflammatory skin disease, other than the investigational product;
Candidate for topical treatment of Acne;
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.

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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 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;
Use of androgen receptor blockers (such as spironolactone or flutamide);
Severe cystic acne, acne conglobate, acne fulminans, or secondary acne;
Use of phototherapy devices, energy-based devices, adhesive cleansing strips, or cosmetic procedures (e.g., facials, peeling, comedo extraction) in the past week;
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;
Prior or current concomitant therapies that would interfere with assessments in the study;

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Subjects with any underlying disease that the Investigator deems uncontrolled, and poses a concern for the subject's safety while participating in the study;
Use of anti-inflammatory medications, salicylic acid; corticosteroids, antibiotics, antibacterials (including benzoyl peroxide-containing products [e.g., benzamycin]), retinoids; other topical acne treatments (e.g., photodynamic therapy, medicated soaps such as those containing benzoyl peroxide, salicylic acid, sulfur, or sodium sulfacetamide) in the past 2 weeks;
Oral retinoid use (e.g., isotretinoin) within 6 months prior to baseline or vitamin A supplements greater than 10,000 units/day within 6 months of baseline;
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;
Use during the study of 1) systemic steroids, 2) topical retinoids to the face, 3) antibiotics known to impact acne, 4) immunosuppressive agents, or immunomodulators;
Facial use of 1) topical steroids, 2) topical anti-inflammatory agents, 3) topical antimycotics, 4) any topical acne 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 Acne Vulgaris.

This is an exploratory Phase 2 trial of BMX-010 in patients with Acne Vulgaris which will be conducted in two parts.

Read the detailed description

Part A is designed to confirm the optimal formulation, strength, and dosing frequency of the study drug in patients with Acne. 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 in patients with Acne. Up to 150 subjects will be enrolled in this part. In both parts, adult subjects with Acne will be enrolled.

Conditions: Acne Vulgaris
Being tested: BMX-010 0.3%
Medical subject headings: Acne Vulgaris

What participants receive

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

BMX-010 0.3%Drug
Safety and efficacy of BMX-010 in topical treatment of acne.

Study groups in NCT03752242
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 Acne of the face. Receives: Drug: BMX-010 0.3%

What is being measured

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

Determine Whether the Optimum Frequency of Topical Application of BMX-010 0.03% is Once a Day or Twice a Day Day or Twice Per Day for a Treatment Interval of 7 to 28 Days.
Assessed by change in the 5-point Investigator Global Assessment (IGA), compared amongst the group that is treated once a day versus twice a day. This will be measured weekly from Days 1-28. The Investigator global assessment scale is a global assessment of disease as the time of evaluation. The lowest number on the scale (0) is clear from disease while the highest number (4) is severe disease. Scores on the scale are: 0, 1, 2, 3, 4
Measured: 28 days
Evaluate the Efficacy of BMX-010 in Treatment of Acne Vulgaris.
Assessed by change in the 5-point Investigator Global Assessment (IGA). This will be measured weekly from Days 1-28, followed by a final assessment two weeks after dosing ends at day 43. Assessed by change in the 5-point Investigator Global Assessment (IGA), compared amongst the group that is treated with study drug versus with placebo. This will be measured weekly from Days 1-28. The Investigator global assessment scale is a global assessment of disease as the time of evaluation. The lowest number on the scale (0) is clear from disease while the highest number (4) is severe disease. Scores on the scale are: 0, 1, 2, 3, 4
Measured: 43 days

Secondary outcomes (2)

Assess the Mean Percent Reduction Change in Inflammatory Lesion Counts From Baseline to End of Study.
Inflammatory lesions will be counted at each study visit and the total change in the count of lesions will be assessed from baseline to day 43.
Measured: 43 days
Assess the Mean Percent Reduction Change in Noninflammatory Lesion Counts From Baseline to End of Study.
Non-Inflammatory lesions will be counted at each study visit.
Measured: 43 days

Timeline

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

3 Jan 201931 Aug 2020

First posted23 Nov 2018
Study start3 Jan 2019
Primary completion31 Aug 2020
Study completion31 Aug 2020

Why it stopped: Enrollment stopped for chemistry work on investigational product.

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 Acne VulgarisStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03752242
Sponsor's protocol ID: BMX-DERM-203
Status last verified: Aug 2023
First submitted: 15 Nov 2018
Last updated: 21 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

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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All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Sep 2023. 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 Acne Vulgaris.
ClinicalTrials.gov ID: NCT03752242
Acronym / sponsor ID: BMX-DERM-203
Conditions: Acne Vulgaris
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Enrollment stopped for chemistry work on investigational product.
Enrolment: 2 participants (actual)
Lead sponsor: BioMimetix JV, LLCIndustry (pharma, biotech, devices)
Study start: 3 Jan 2019 (actual)
Primary completion: 31 Aug 2020 (actual)
Study completion: 31 Aug 2020 (actual)
First posted: 23 Nov 2018 (actual)
Results: Posted 21 Sep 2023

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 Acne Vulgaris which will be conducted in two parts.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
BMX-010 0.03%	Experimental	Drug: BMX-010 0.3%Approximately 30 subjects will receive BMX-010 0.03% for 7-28 days to be applied topically to Acne 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 (10 listed)

Male or female, at least 18 years of age;
A clinical diagnosis of mild to severe facial Acne Vulgaris; Subjects may also have acne at other body sites;
Screening and Baseline IGA score > 2 (greater than or equal to 2);
Willing to refrain from using any topical or systemic treatments for inflammatory skin disease, other than the investigational product;
Candidate for topical treatment of Acne;

Key exclusion criteria (22 listed)

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;
Use of androgen receptor blockers (such as spironolactone or flutamide);
Severe cystic acne, acne conglobate, acne fulminans, or secondary acne;
Use of phototherapy devices, energy-based devices, adhesive cleansing strips, or cosmetic procedures (e.g., facials, peeling, comedo extraction) in the past week;
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;

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-010 0.3%Safety and efficacy of BMX-010 in topical treatment of acne.	Drug	BMX-010 0.03%

Primary outcome

Determine Whether the Optimum Frequency of Topical Application of BMX-010 0.03% is Once a Day or Twice a Day Day or Twice Per Day for a Treatment Interval of 7 to 28 Days.
Time frame: 28 days
Assessed by change in the 5-point Investigator Global Assessment (IGA), compared amongst the group that is treated once a day versus twice a day. This will be measured weekly from Days 1-28. The Investigator global assessment scale is a global assessment of disease as the time of evaluation. The lowest number on the scale (0) is clear from disease while the highest number (4) is severe disease. Scores on the scale are: 0, 1, 2, 3, 4
Evaluate the Efficacy of BMX-010 in Treatment of Acne Vulgaris.
Time frame: 43 days
Assessed by change in the 5-point Investigator Global Assessment (IGA). This will be measured weekly from Days 1-28, followed by a final assessment two weeks after dosing ends at day 43. Assessed by change in the 5-point Investigator Global Assessment (IGA), compared amongst the group that is treated with study drug versus with placebo. This will be measured weekly from Days 1-28. The Investigator global assessment scale is a global assessment of disease as the time of evaluation. The lowest number on the scale (0) is clear from disease while the highest number (4) is severe disease. Scores on the scale are: 0, 1, 2, 3, 4

2 secondary outcomes

Assess the Mean Percent Reduction Change in Inflammatory Lesion Counts From Baseline to End of Study.
Time frame: 43 days
Assess the Mean Percent Reduction Change in Noninflammatory Lesion Counts From Baseline to End of Study.
Time frame: 43 days

Results and safety

Results posted to the registry on 21 Sep 2023, 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%	2	2

Primary outcome: Determine Whether the Optimum Frequency of Topical Application of BMX-010 0.03% is Once a Day or Twice a Day Day or Twice Per Day for a Treatment Interval of 7 to 28 Days.

Time frame: 28 days. Mean (Standard Deviation). Unit: score on a scale

Measure	BMX-010 0.03% n = 2
Value	2.5 (.5)

Population analysed: 2 subjects enrolled and both were treated twice a day, so we were unable to determine this outcome. We will report the IGA scores collected, however this data is insufficient to determine optimal dosing (once a day or twice a day), since the only subjects enrolled were treated twice a day.

Primary outcome: Evaluate the Efficacy of BMX-010 in Treatment of Acne Vulgaris.

Time frame: 43 days. Mean (Standard Deviation). Unit: score on a scale

Measure	BMX-010 0.03% n = 2
Value	2.5 (.5)

Population analysed: all of the subjects enrolled in the study

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment Period through Day 43 Final Clinic Visit. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BMX-010 0.03%	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Limitations and caveats (from the sponsor): The clinical trial was stopped after enrollment of 2 subjects for re-formulation of investigational product. Therefore, due to the small sample size data is uninterpretable.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Acne Vulgaris

Not yet recruitingPhase 3
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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 0.3% in people with Acne Vulgaris, 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 10 inclusion and 22 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 21 Sep 2023. 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 21 Sep 2023). 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?

Determine Whether the Optimum Frequency of Topical Application of BMX-010 0.03% is Once a Day or Twice a Day Day or Twice Per Day for a Treatment Interval of 7 to 28 Days. (time frame: 28 days). The study lists 2 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 NCT03752242.

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 21 Sep 2023.