AcnePhase 4NCT02695446

Administration of Oral Extended Release Minocycline for Assessment of Skin and Plasma Concentrations of Minocycline

A Phase 4 study testing Minocycline in people with Acne, run by BioPharmX, Inc. at 1 site in United States.

Completed

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

Trial summary

The primary objective of this study is to evaluate the skin and plasma concentrations of minocycline in subjects undergoing treatment of acne vulgaris with oral extended release minocycline. Acne lesion counts and safety/tolerance of the treatment will also be evaluated. Read more about this study

Who is it for?: Ages 14 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Acne
What is being tested?: Minocycline
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited States
Study dates: Mar 2016to May 2016
Phase: Phase 4
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 14 to 40 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Otherwise healthy male and female subjects 14 to 40 years of age
Moderate to severe inflammatory facial acne vulgaris (EGSA score of 3-5)
Subjects not using oral or topical antibiotic products for at least 30 days prior to study entry and willing to refrain from use of oral and topical antibiotics for the duration of study participation
Subjects not currently using and willing to refrain from use of other topical acne products for the duration of study participation

Who cannot join

Mild, non-inflammatory or nodular acne vulgaris
Have current or previous skin cancer
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 during the study period or breastfeeding
Have conditions or factors that the PI believes may affect the response of the skin or the interpretation of the results
Participation in any clinical study within the previous 30 days or plan concurrent participation in other studies

Trial locations and contacts

1 site in 1 country.

United States1 site

KGL Skin Study Center
Broomall, Pennsylvania, 19008

Other trials in United States

About this study

Read the detailed description

This will be an open label, non randomized, interventional pilot study evaluating the plasma and skin levels of minocycline in 10 subjects with moderate to severe acne vulgaris. Subjects with non inflammatory acne of nodular acne will not be enrolled. Subjects will be on an oral extended release minocycline regimen of up to 2mg/kg once a day for 4 weeks.

Steady state levels of minocycline in plasma and skin will be determined.

Conditions: Acne
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 MCN
Oral extended release minocycline

Study groups in NCT02695446
Study group	Role	What they receive
Oral ER Minocycline - Up to 2mg/kg	Other	Oral extended release minocycline - up to 2mg/kg once a day for 30 days. Receives: Drug: Minocycline

What is being measured

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

Plasma Minocycline Level
Measured: Assessed at week 2 and week 4; reported at week 4

Secondary outcomes (1)

Skin/Dermal Levels of Minocycline
Measured: Measured at 2 weeks in half the subjects, 4 week biopsies not performed per early stopping rules

Timeline

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

Mar 2016May 2016

First posted1 Mar 2016 (estimated)
Study startMar 2016
Primary completionApr 2016
Study completionMay 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 AcneStudies 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 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02695446
Sponsor's protocol ID: BPX-01-C01
Status last verified: Aug 2017
First submitted: 18 Feb 2016
Last updated: 14 Sep 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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.
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RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
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RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
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Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
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Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
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All Acne trials

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: Administration of Oral Extended Release Minocycline for Assessment of Skin and Plasma Concentrations of Minocycline
ClinicalTrials.gov ID: NCT02695446
Acronym / sponsor ID: BPX-01-C01
Conditions: Acne
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: BioPharmX, Inc.Industry (pharma, biotech, devices)
Study start: Mar 2016
Primary completion: Apr 2016 (actual)
Study completion: May 2016 (actual)
First posted: 1 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.

Detailed description

Steady state levels of minocycline in plasma and skin will be determined.

Study design

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

Arm	Type	Receives
Oral ER Minocycline - Up to 2mg/kg	Other	Drug: MinocyclineOral extended release minocycline - up to 2mg/kg once a day for 30 days.

Who may qualify

Ages: 14 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

Otherwise healthy male and female subjects 14 to 40 years of age
Moderate to severe inflammatory facial acne vulgaris (EGSA score of 3-5)
Subjects not using oral or topical antibiotic products for at least 30 days prior to study entry and willing to refrain from use of oral and topical antibiotics for the duration of study participation
Subjects not currently using and willing to refrain from use of other topical acne products for the duration of study participation

Key exclusion criteria (6 listed)

Mild, non-inflammatory or nodular acne vulgaris
Have current or previous skin cancer
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 during the study period or breastfeeding
Have conditions or factors that the PI believes may affect the response of the skin or the interpretation of the results

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: MCNOral extended release minocycline	Drug	Oral ER Minocycline - Up to 2mg/kg

Primary outcome

Plasma Minocycline Level
Time frame: Assessed at week 2 and week 4; reported at week 4

1 secondary outcome

Skin/Dermal Levels of Minocycline
Time frame: Measured at 2 weeks in half the subjects, 4 week biopsies not performed per early stopping rules

Results and safety

Results posted to the registry on 14 Sep 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oral ER Minocycline - Up to 2mg/kg	12	12

Primary outcome: Plasma Minocycline Level

Time frame: Assessed at week 2 and week 4; reported at week 4. Mean (Standard Deviation). Unit: ng/ml

Measure	Oral ER Minocycline - Up to 2mg/kg n = 12
Value	421 (244)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oral ER Minocycline - Up to 2mg/kg	0 of 12 (0%)	1 of 12 (8.3%)	0 of 12

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

Related trials for Acne

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)
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RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
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Active, not recruiting
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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 4 study testing Minocycline in people with Acne, 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 4 inclusion and 6 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

Plasma Minocycline Level (time frame: Assessed at week 2 and week 4; reported at week 4). 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 NCT02695446.

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.