Acne VulgarisNCT01662349
Safety Study of Plasma Treatment System to Treat Back Acne
A study testing MOE Antimicrobial Plasma Treatment System in people with Acne Vulgaris, run by Moe Medical Devices at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety of treating human skin with atmospheric plasma and get an initial evaluation of the efficacy of this treatment for acne. 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?
- MOE Antimicrobial Plasma Treatment System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jun 2013
- Phase
- Interventional
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and non-pregnant, non-nursing females age 18-40 years old.
- Presence of clinically-evident back acne.
- Minimum of 20 non-inflammatory lesions (open and closed comedones)
- Minimum of 30 total lesions (sum of inflammatory and non-inflammatory)
- Subject must have measurable sebum production.
- Subjects must be in generally good health.
- Must be able and willing to comply with the requirements of the protocol.
Who cannot join
- Any nodulo-cystic lesions at Baseline
- Pregnancy or breast feeding
- Use of acne devices or systemic therapy with antibiotics within four months prior to start and throughout the duration of the study
- Intake of any oral retinoids within four months prior to study start and throughout the duration of the study
- Topical use of topical retinoids within two weeks prior to study start and throughout the duration of the study
- Topical use of antibiotics, steroids and/or other non-retinoid topical acne products within two weeks prior to study start and throughout the duration of the study
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- Use of an experimental drug or device within 30 days prior to study start;
- Intake of hormonal therapy within 3 months prior to study start
- Use of topical products on the back containing glycolic or other acids, masks, washes or soaps containing benzoyl peroxide or salicylic acid, non mild cleansers or moisturizers containing retinol, salicylic or α- or β-hydroxy acids.
- Concomitant use of mega-doses of certain vitamins, such as vitamin D (>2000IU QD) vitamin B12, haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital.
- Procedures on the skin of the back such as chemical or laser peel, microdermabrasion, photodynamic therapy) within the past 2 weeks or during the study.
- History or evidence of other skin conditions or diseases that may require concurrent therapy or may interfere with the evaluation of the study medication
- Any significant medical conditions that could confound the interpretation of the study results.
- History of/or current skin cancer cancer
- Use of tanning booths, sun lamps within the past 2 weeks or during the study
- Any metallic implants or prostheses in the vicinity of the treatment site (such as shoulders, back, spine, pacemakers, etc.).
- Any known photosensitivity disorders felt by the investigators to preclude safe inclusion in the study.
- History of significant post-inflammatory hyperpigmentation at the sites of acne lesions.
- History of or is currently immunocompromised.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Unit for Research Trials and Outcomes in Skin (CURTIS)
Boston, Massachusetts, 02114
About this study
Official title: A Single Center, Pilot Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Plasma Treatment System in Treating Back Acne
The purpose of this study is to evaluate the safety of treating human skin with atmospheric plasma and get an initial evaluation of the efficacy of this treatment for acne.
- Conditions
- Acne Vulgaris
- Being tested
- MOE Antimicrobial Plasma Treatment System
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOE Antimicrobial Plasma Treatment SystemDevice
Plasma applied to back for up to 20 minutes, twice/week for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Plasma | Experimental | Plasma applied to back for up to 20 minutes, twice/week for 4 weeks Receives: Device: MOE Antimicrobial Plasma Treatment System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of reported adverse events
Measured: Change from Baseline to 1 month post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: The study was stopped due to other research priorities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moe Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexandra B. Kimball, MD, Principal investigator, Partners Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662349
- Sponsor's protocol ID
- MOE - 121
- Status last verified
- Sep 2017
- First submitted
- 2 Aug 2012
- Last updated
- 14 Sep 2017
- Results posted
- 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
- A Single Center, Pilot Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Plasma Treatment System in Treating Back Acne
- ClinicalTrials.gov ID
- NCT01662349
- Acronym / sponsor ID
- MOE - 121
- Conditions
- Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped due to other research priorities.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Moe Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 10 Aug 2012 (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.
The purpose of this study is to evaluate the safety of treating human skin with atmospheric plasma and get an initial evaluation of the efficacy of this treatment for acne.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Plasma | Experimental | Device: MOE Antimicrobial Plasma Treatment SystemPlasma applied to back for up to 20 minutes, twice/week for 4 weeks |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Males and non-pregnant, non-nursing females age 18-40 years old.
- Presence of clinically-evident back acne.
- Minimum of 20 non-inflammatory lesions (open and closed comedones)
- Minimum of 30 total lesions (sum of inflammatory and non-inflammatory)
- Subject must have measurable sebum production.
Key exclusion criteria (19 listed)
- Any nodulo-cystic lesions at Baseline
- Pregnancy or breast feeding
- Use of acne devices or systemic therapy with antibiotics within four months prior to start and throughout the duration of the study
- Intake of any oral retinoids within four months prior to study start and throughout the duration of the study
- Topical use of topical retinoids within two weeks prior to study start and throughout the duration of the 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 |
|---|---|---|
| MOE Antimicrobial Plasma Treatment SystemPlasma applied to back for up to 20 minutes, twice/week for 4 weeks | Device | Plasma |
Primary outcome
Change in number of reported adverse events
Time frame: Change from Baseline to 1 month post-treatment
Results and safety
The study was stopped early (reason given: The study was stopped due to other research priorities.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
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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.
Alexandra B. Kimball, MD principal investigator
Partners Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOE Antimicrobial Plasma Treatment System in people with Acne Vulgaris, run by Moe Medical Devices 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 19 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 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.
Are results available for this study?
The study was stopped early (reason given: The study was stopped due to other research priorities.). Results are not available in the source record.
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 in number of reported adverse events (time frame: Change from Baseline to 1 month post-treatment). 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; AzTrials last refreshed its copy on 7 Nov 2026.