Open Label Photo-Documentation Study Of BPX-01 Minocycline Gel

A Phase 2 study testing Minocycline in people with Acne Vulgaris, run by BioPharmX, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a multi center open label study intended to provide photo documentation and time to response data for BPX-01 1 and 2% minocycline topical gel for the treatment of moderate to severe non-nodular inflammatory acne vulgarism. Read more about this study

Who is it for?: Ages 18 to 40 years
Conditions the study is for: Acne Vulgaris
What is being tested?: Minocycline
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 2 sitesUnited States
Study dates: 13 Mar 2017to 1 Jun 2018
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
No healthy volunteers
Adult

Who may be able to join

moderate to severe inflammatory non-nodular acne vulgaris

Who cannot join

female subject who is breastfeeding, pregnant or planning a pregnancy during the study
have other skin condition or disease that would interfere with the study
have had any prior treatment with minocycline
have a known or suspected allergy to tetracycline class products
have used OTC medications for the treatment of facial acne within the last 14 days
have used any prescription topical or oral medications for the treatment of facial acne in the last 28 days
have had a facial procedure (chemical peel, dermabrasion, laser, etc) within the last 8 weeks

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Study Center
Coral Gables, Florida, 33146
Study Center
Las Vegas, Nevada, 89128

Other trials in United States

About this study

Official title: An Open Label Study to Document the Treatment Effect of 1 and 2% BPX-01 Minocycline Topical Gel in Moderate to Severe Inflammatory Non-nodular Acne Vulgaris (Protocol Number BPX-01-C04)

Read the detailed description

This was a 12-week, multi-center, open label, two-arm study. Subjects will be assigned to treatment with 1% or 2% BPX-01 gel. Subjects will apply 1g of the gel as a thin film to the entire face at least 30 minutes before bedtime each night for 12 weeks. Lesion counts, IGA, and Patient-Reported Outcomes (PGI-S and PGI-I) will be performed to assess efficacy. Photographs will be taken to document treatment effect.

Safety will be assessed with the vital signs, brief physical examination, clinical laboratory tests, cutaneous tolerance score, incidence of minocycline-induced skin hyperpigmentation, incidence of visual disturbances and/or headaches suggestive of pseudotumor cerebri, incidence of product related facial staining and collection of adverse events.

Conditions: Acne Vulgaris
Being tested: Minocycline
Medical subject headings: Acne Vulgaris

What participants receive

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

MinocyclineDrug
Also called BPX-01
BPX-01 1 or 2% topical gel will be applied to face once daily

Study groups in NCT02946788
Study group	Role	What they receive
BPX-01 1%	Experimental	BPX-01 1% minocycline topical gel Receives: Drug: Minocycline
BPX-01 2%	Experimental	BPX-01 2% minocycline topical gel Receives: Drug: Minocycline

What is being measured

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

Change From Baseline in Inflammatory Lesion Counts at Week 12
difference in number of inflammatory lesions at week 12 as compared to baseline
Measured: 12 weeks

Timeline

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

13 Mar 20171 Jun 2018

First posted27 Oct 2016 (estimated)
Study start13 Mar 2017
Primary completion1 Jun 2018
Study completion1 Jun 2018

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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02946788
Sponsor's protocol ID: BPX-01-C04
Status last verified: Jul 2022
First submitted: 25 Oct 2016
Last updated: 26 Jul 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: 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

Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal

All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label Study to Document the Treatment Effect of 1 and 2% BPX-01 Minocycline Topical Gel in Moderate to Severe Inflammatory Non-nodular Acne Vulgaris (Protocol Number BPX-01-C04)
ClinicalTrials.gov ID: NCT02946788
Acronym / sponsor ID: BPX-01-C04
Conditions: Acne Vulgaris
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: BioPharmX, Inc.Industry (pharma, biotech, devices)
Study start: 13 Mar 2017 (actual)
Primary completion: 1 Jun 2018 (actual)
Study completion: 1 Jun 2018 (actual)
First posted: 27 Oct 2016 (estimated)
Results: Posted 26 Jul 2022

Clinical summary

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

Detailed description

Study design

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

Arm	Type	Receives
BPX-01 1%	Experimental	Drug: MinocyclineBPX-01 1% minocycline topical gel
BPX-01 2%	Experimental	Drug: MinocyclineBPX-01 2% minocycline topical gel

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (1 listed)

moderate to severe inflammatory non-nodular acne vulgaris

Key exclusion criteria (7 listed)

female subject who is breastfeeding, pregnant or planning a pregnancy during the study
have other skin condition or disease that would interfere with the study
have had any prior treatment with minocycline
have a known or suspected allergy to tetracycline class products
have used OTC medications for the treatment of facial acne within the last 14 days

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
MinocyclineAlso: BPX-01BPX-01 1 or 2% topical gel will be applied to face once daily	Drug	BPX-01 1%, BPX-01 2%

Primary outcome

Change From Baseline in Inflammatory Lesion Counts at Week 12
Time frame: 12 weeks
difference in number of inflammatory lesions at week 12 as compared to baseline

Results and safety

Results posted to the registry on 26 Jul 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BPX-01 1%	8	8
BPX-01 2%	10	9

Primary outcome: Change From Baseline in Inflammatory Lesion Counts at Week 12

Time frame: 12 weeks. Mean (Full Range). Unit: inflammatory lesions

Measure	BPX-01 1% n = 8	BPX-01 2% n = 10
Value	22.3 (10 to 32)	19.0 (11 to 40)

Adverse events

Time frame: 8 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BPX-01 1%	0 of 8 (0%)	2 of 8 (25%)	0 of 8
BPX-01 2%	0 of 10 (0%)	3 of 10 (30%)	0 of 10

Limitations and caveats (from the sponsor): not powered for statistical significance. Small, unblinded study

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Acne Vulgaris

Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal

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.

AnnaMarie Daniels study director

BioPharmX, Inc.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Minocycline in people with Acne Vulgaris, run by BioPharmX, Inc. at 2 sites 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 1 inclusion and 7 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 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 26 Jul 2022). 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?

Change From Baseline in Inflammatory Lesion Counts at Week 12 (time frame: 12 weeks). 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 NCT02946788.

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 26 Jul 2022.