Acne VulgarisPhase 2NCT02709096
BPX-01 Minocycline 1% Topical Gel for Reduction of Propionibacterium Acnes
A Phase 2 study testing BPX-01, 1% Topical Gel in people with Acne Vulgaris, run by BioPharmX, Inc. at 1 site in United States.
Trial summary
This is a Phase 2a study which is being conducted in healthy volunteers in order to evaluate the comparative reduction of Propionibacterium acnes in-vivo following once daily topical administration of BPX-01 Minocycline 1% Topical Gel (BPX-01) or BPX-01 Vehicle control. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- BPX-01, 1% Topical Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Jun 2016
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be a healthy, adult male and/or female volunteer 18 to 40 years of age with no past or present history of any significant disease based on PI discretion;
- If female, must be post-menopausal, surgically sterile, or using effective birth control methods with a negative urine pregnancy test at the Screening and Baseline visits (female subjects of childbearing potential only);
- Show a high degree of fluorescence of the face under a Wood's lamp at the screening visit.
- Be willing to refrain from using antimicrobial topical products for the duration of study participation;
- Be willing to return to the study center for all study visits;
- Be willing to follow all study instructions and adhere to study restrictions;
- Provide informed consent to the study procedures and restrictions
Who cannot join
- Have a history of skin disease or presence of skin condition the PI believes would interfere with the study;
- Females who report that they are pregnant, planning a pregnancy or breastfeeding or those females who are of child bearing potential, that test positive with a urine pregnancy test;
- Have conditions or factors that the PI believes may affect the response of the skin or the interpretation of the results;
- Participated in any clinical study within the previous 30 days, be concurrently participating in other studies, or be involved in any aspect of test administration;
- Use of topical or systemic antibiotics or other products within the previous 4 weeks prior to baseline, that influence P. acnes counts;
- Are known to be allergic to any of the test product(s) or any components in the test product(s);
- Have a history of significant medical condition/disease that the PI believes may affect the response of the skin or the interpretation of the results;
- Has any other condition that, in the opinion of the Investigator or his designee, could interfere with the subject's ability to use the treatment as instructed, alter their treatment response, or affect their ability to complete the study
Trial locations and contacts
1 site in 1 country.
About this study
This is a Phase 2a study which is being conducted in healthy volunteers in order to evaluate the comparative reduction of Propionibacterium acnes in-vivo following once daily topical administration of BPX-01 Minocycline 1% Topical Gel (BPX-01) or BPX-01 Vehicle control.
Read the detailed description
The objective of this study is to evaluate the comparative reduction of Propionibacterium acnes (P. acnes) in-vivo following once daily topical administration of BPX-01 Minocycline 1% Topical Gel or BPX-01 Vehicle control Gel.
A secondary objective is to assess the tolerance of the treatment regimen versus a vehicle control. Safety laboratory data (chemistry and hematology) and plasma levels of minocycline are also of significant interest to the sponsor.
This is a single center, randomized, double blind, two-cell, vehicle controlled P. acnes study. All subjects will be randomized 2:1 to 1% BPX-01 or vehicle control to be applied as a topical gel once daily for four (4) weeks.
This is a six (6) week study with a four (4) week treatment period and a two (2) week post treatment follow up visit. The clinical endpoint is in-vivo quantification of P.acnes. The safety/tolerance endpoints are; observer reported: erythema, scaling-peeling, edema, and subject reported: tightness, burning-stinging, and itching. Plasma levels of minocycline and basic hematology and chemistry laboratory values will be collected.
- Conditions
- Acne Vulgaris
- Being tested
- BPX-01, 1% Topical Gel, BPX-01 Vehicle Gel
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BPX-01, 1% Topical GelDrug
Also called BPX-01 Topical Gel
topical gel, applied to the forehead, cheeks, nose and chin
BPX-01 Vehicle GelDrug
Also called BPX-01 Vehicle
topical gel, applied to the forehead, cheeks, nose and chin
| Study group | Role | What they receive |
|---|---|---|
| BPX-01, 1% Topical Gel | Experimental | BPX-01, 1% Topical Gel; applied once daily to the face for four weeks. Receives: Drug: BPX-01, 1% Topical Gel |
| BPX-01, Vehicle Gel | Placebo comparator | BPX-01, Vehicle Gel; applied once daily to the face for four weeks. Receives: Drug: BPX-01 Vehicle Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Logarithmic Change in Colony Counts of Facial Propionibacterium Acnes
- Acnes cultures will be collected using the modified Kligman Method at each study visit. After plating, the samples will be cultured for 7 days and then evaluated.
Measured: Cultures will be evaluated at Baseline, Week 1, Week 2, Week 4 and Week 6. Values reported at week 4 compared to baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2016
- Study completionJun 2016
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioPharmX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stuart Lessin, MD, Principal investigator, KGL, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02709096
- Sponsor's protocol ID
- BPX-01-C02
- Status last verified
- Aug 2017
- First submitted
- 10 Mar 2016
- Last updated
- 14 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BPX-01 Minocycline 1% Topical Gel for Reduction of Propionibacterium Acnes
- ClinicalTrials.gov ID
- NCT02709096
- Acronym / sponsor ID
- BPX-01-C02
- Conditions
- Acne Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- BioPharmX, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 15 Mar 2016 (estimated)
- Results
- Posted 14 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2a study which is being conducted in healthy volunteers in order to evaluate the comparative reduction of Propionibacterium acnes in-vivo following once daily topical administration of BPX-01 Minocycline 1% Topical Gel (BPX-01) or BPX-01 Vehicle control.
Detailed description
The objective of this study is to evaluate the comparative reduction of Propionibacterium acnes (P. acnes) in-vivo following once daily topical administration of BPX-01 Minocycline 1% Topical Gel or BPX-01 Vehicle control Gel.
A secondary objective is to assess the tolerance of the treatment regimen versus a vehicle control. Safety laboratory data (chemistry and hematology) and plasma levels of minocycline are also of significant interest to the sponsor.
This is a single center, randomized, double blind, two-cell, vehicle controlled P. acnes study. All subjects will be randomized 2:1 to 1% BPX-01 or vehicle control to be applied as a topical gel once daily for four (4) weeks.
This is a six (6) week study with a four (4) week treatment period and a two (2) week post treatment follow up visit. The clinical endpoint is in-vivo quantification of P.acnes. The safety/tolerance endpoints are; observer reported: erythema, scaling-peeling, edema, and subject reported: tightness, burning-stinging, and itching. Plasma levels of minocycline and basic hematology and chemistry laboratory values will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BPX-01, 1% Topical Gel | Experimental | Drug: BPX-01, 1% Topical GelBPX-01, 1% Topical Gel; applied once daily to the face for four weeks. |
| BPX-01, Vehicle Gel | Placebo comparator | Drug: BPX-01 Vehicle GelBPX-01, Vehicle Gel; applied once daily to the face for four weeks. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Be a healthy, adult male and/or female volunteer 18 to 40 years of age with no past or present history of any significant disease based on PI discretion;
- If female, must be post-menopausal, surgically sterile, or using effective birth control methods with a negative urine pregnancy test at the Screening and Baseline visits (female subjects of childbearing potential only);
- Show a high degree of fluorescence of the face under a Wood's lamp at the screening visit.
- Be willing to refrain from using antimicrobial topical products for the duration of study participation;
- Be willing to return to the study center for all study visits;
Key exclusion criteria (8 listed)
- Have a history of skin disease or presence of skin condition the PI believes would interfere with the study;
- Females who report that they are pregnant, planning a pregnancy or breastfeeding or those females who are of child bearing potential, that test positive with a urine pregnancy test;
- Have conditions or factors that the PI believes may affect the response of the skin or the interpretation of the results;
- Participated in any clinical study within the previous 30 days, be concurrently participating in other studies, or be involved in any aspect of test administration;
- Use of topical or systemic antibiotics or other products within the previous 4 weeks prior to baseline, that influence P. acnes counts;
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 |
|---|---|---|
| BPX-01, 1% Topical GelAlso: BPX-01 Topical Geltopical gel, applied to the forehead, cheeks, nose and chin | Drug | BPX-01, 1% Topical Gel |
| BPX-01 Vehicle GelAlso: BPX-01 Vehicletopical gel, applied to the forehead, cheeks, nose and chin | Drug | BPX-01, Vehicle Gel |
Primary outcome
Logarithmic Change in Colony Counts of Facial Propionibacterium Acnes
Time frame: Cultures will be evaluated at Baseline, Week 1, Week 2, Week 4 and Week 6. Values reported at week 4 compared to baseline.
P. Acnes cultures will be collected using the modified Kligman Method at each study visit. After plating, the samples will be cultured for 7 days and then evaluated.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Stuart Lessin, MD principal investigator
KGL, Inc.
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 BPX-01, 1% Topical Gel in people with Acne Vulgaris, run by BioPharmX, Inc. 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 14 Sep 2017. 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. Some participants in this study may receive a placebo. 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 14 Sep 2017). 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?
Logarithmic Change in Colony Counts of Facial Propionibacterium Acnes (time frame: Cultures will be evaluated at Baseline, Week 1, Week 2, Week 4 and Week 6. Values reported at week 4 compared to baseline.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2017.