AcneNCT03009903
Evaluation and Detection of Facial Propionibacterium Acnes Bacteria and Phage
An observational study of Acne, run by MBcure Ltd.
Trial summary
This multi-center, outpatient study will extract and evaluate the presence of facial P. acnes bacteria and phage strains using pore strips on up to 400 human subjects. Read more about this study
- Who is it for?
- Ages 14 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Subjects will be male or female, ages 14-50. Healthy subjects and acne diagnosed subjects.
Who may be able to join
- Adults between 14 to 50 years of age inclusive at the time of signing the informed consent
- Able to provide written informed consent
- Subjects who are willing to undergo pore strip treatment using the cosmetically acceptable pore strip product
- Subjects who are willing to provide comprehensive demographic data using questionnaires
Who cannot join
- Unwilling or unable to follow the procedures outlined in the protocol
- Subjects treated with isotretinoin or tretinion during the 6 months prior to visit 1
- Subjects treated with immunosuppressant agents
- Pregnant subjects
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation and Detection of Facial Propionibacterium Acnes Bacteria and Phage Using Pore Strips in Humans
This multi-center, outpatient study will extract and evaluate the presence of facial P. acnes bacteria and phage strains using pore strips on up to 400 human subjects.
Read the detailed description
This multi-center, outpatient study will extract and evaluate the presence of facial P. acnes bacteria and phage strains using pore strips on up to 400 human subjects. An additional P. acnes visual detection method (VISIOPOR ® PP34N) will be used in this study as per PI decision to explore whether there is a correlation between P. acnes bacterial presence and fluorescent signal.
- Conditions
- Acne
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| P. acne subjects | 14-50 year of age, P. acne diagnosed subjects | |
| None P. acne subjects | 14-50 year of age, none P. acne diagnosed subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection and analysis of facial P. acnes presence
Measured: Day 0 and week 8 (optional)
Secondary outcomes (1)
Assessing correlation between phage and P. acnes using: a. Demographic Questionnaire b. Visual Supportive Methodology (VISIOPOR ® PP34N) as per PI decision.
Measured: Day 0 and week 8 (optional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJul 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MBcure Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Shapiro, MD, Principal investigator, Maccabi Healthcare Services, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009903
- Sponsor's protocol ID
- MBC-CL-01-2016
- Status last verified
- Dec 2016
- First submitted
- 30 Dec 2016
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 2 sites to be activated. Dr. Shapiro is considered as PI in both sites
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Detection of Facial Propionibacterium Acnes Bacteria and Phage Using Pore Strips in Humans
- ClinicalTrials.gov ID
- NCT03009903
- Acronym / sponsor ID
- MBC-CL-01-2016
- Conditions
- Acne
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- MBcure LtdIndustry (pharma, biotech, devices)
- Study start
- Jan 2017
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 4 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multi-center, outpatient study will extract and evaluate the presence of facial P. acnes bacteria and phage strains using pore strips on up to 400 human subjects.
Detailed description
This multi-center, outpatient study will extract and evaluate the presence of facial P. acnes bacteria and phage strains using pore strips on up to 400 human subjects. An additional P. acnes visual detection method (VISIOPOR ® PP34N) will be used in this study as per PI decision to explore whether there is a correlation between P. acnes bacterial presence and fluorescent signal.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P. acne subjects | – | –14-50 year of age, P. acne diagnosed subjects |
| None P. acne subjects | – | –14-50 year of age, none P. acne diagnosed subjects |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Subjects will be male or female, ages 14-50. Healthy subjects and acne diagnosed subjects.
Key inclusion criteria (4 listed)
- Adults between 14 to 50 years of age inclusive at the time of signing the informed consent
- Able to provide written informed consent
- Subjects who are willing to undergo pore strip treatment using the cosmetically acceptable pore strip product
- Subjects who are willing to provide comprehensive demographic data using questionnaires
Key exclusion criteria (4 listed)
- Unwilling or unable to follow the procedures outlined in the protocol
- Subjects treated with isotretinoin or tretinion during the 6 months prior to visit 1
- Subjects treated with immunosuppressant agents
- Pregnant subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detection and analysis of facial P. acnes presence
Time frame: Day 0 and week 8 (optional)
1 secondary outcome
Assessing correlation between phage and P. acnes using: a. Demographic Questionnaire b. Visual Supportive Methodology (VISIOPOR ® PP34N) as per PI decision.
Time frame: Day 0 and week 8 (optional
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
- Individual participant dataSharing planned: No. 2 sites to be activated. Dr. Shapiro is considered as PI in both sites
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)
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.
Jonathan Shapiro, MD principal investigator
Maccabi Healthcare Services, Israel
Questions about this trial
What is this clinical trial studying?
An observational study of Acne, run by MBcure Ltd.
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 4 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: status not confirmed, as of the sponsor's last update on 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Shapiro, MD (972.50.5759516, jonmidi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection and analysis of facial P. acnes presence (time frame: Day 0 and week 8 (optional)). 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 4 Jan 2017.