Actinic KeratosisNCT02759900
Using a Cold Atmospheric Plasma Device to Treat Skin Disorders
A study testing Non-thermal, atmospheric plasma to treat skin lesions and acne and Indirect non-thermal, atmospheric plasma to treat hair loss and acne in people with Actinic Keratosis and Acne/Rosacea, run by The Skin Center Dermatology Group at 1 site in United States.
Trial summary
This study examines the efficacy of a non-thermal, atmospheric plasma device in the treatment of skin disorders Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Actinic Keratosis, Acne/Rosacea, Verruca Plana
- What is being tested?
- Non-thermal, atmospheric plasma to treat skin lesions and acne and Indirect non-thermal, atmospheric plasma to treat hair loss and acne
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Jan 2025
- 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 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diagnoses of target conditions
- ability to complete study protocol
Who cannot join
- based on specific condition
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The Skin Center Dermatology Group
New City, New York, 10956
Peter C Friedman, MD, PhD, 845-352-0500, pbc9@columbia.edu
About this study
This study examines the efficacy of a non-thermal, atmospheric plasma device in the treatment of skin disorders
Read the detailed description
The study uses non-thermal atmospheric pressure plasma to treat target conditions. The patients are monitored at set intervals for efficacy and adverse effects using investigator's assessment and imaging techniques
- Conditions
- Actinic Keratosis, Acne/Rosacea, Verruca Plana, Tinea, Molluscum Contagiosum, Bowen's Disease
- Being tested
- Non-thermal, atmospheric plasma to treat skin lesions and acne, Indirect non-thermal, atmospheric plasma to treat hair loss and acne
- Medical subject headings
- Keratosis, Actinic, Rosacea, Tinea, Molluscum Contagiosum, Bowen's Disease, Warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-thermal, atmospheric plasma to treat skin lesions and acneDevice
Non-thermal, atmospheric plasma treatment of affected area or lesions using a nanosecond dielectric barrier discharge plasma device
Indirect non-thermal, atmospheric plasma to treat hair loss and acneDevice
A compound of non-thermal, atmospheric plasma and medium is delivered to or generated at the target area. Plasma is generated using either microsecond dielectric barrier discharge plasma device or PiezoBrush (a helium jet plasma). The medium is an aqueous alcohol solution
| Study group | Role | What they receive |
|---|---|---|
| Non-thermal atmospheric plasma treatment | Experimental | Device treatment Receives: Device: Non-thermal, atmospheric plasma to treat skin lesions and acne |
| Indirect non-thermal atmospheric plasma treatment | Experimental | A compound of non-thermal atmospheric plasma and medium is used to treat the target by direct application or by on-site generation of the compound Receives: Device: Indirect non-thermal, atmospheric plasma to treat hair loss and acne |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement
The outcome is the presence or lack of clinical improvement in the investigator's global assessment and reviewing photo-documentation as well as reflectance confocal microscopy study investigator's global assessment and reviewing photo-documentation
Measured: 1-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study startJan 2016
- Primary completionMar 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Actinic KeratosisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Skin Center Dermatology Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02759900
- Sponsor's protocol ID
- 20130084
- Status last verified
- Apr 2022
- First submitted
- 26 Apr 2016
- Last updated
- 12 Apr 2022
- Results posted
- No
Publications
Friedman PC, Fridman G, Fridman A. Cold atmospheric pressure plasma clears molluscum contagiosum. Exp Dermatol. 2023 Apr;32(4):562-563. doi: 10.1111/exd.14695. Epub 2022 Nov 3. No abstract available.
PubMed 36302167Malik S, Gill M, Fridman G, Fridman A, Friedman PC. Cold atmospheric plasma reduces demodex count on the face comparably to topical ivermectin, as measured by reflectance confocal microscopy. Exp Dermatol. 2022 Sep;31(9):1352-1354. doi: 10.1111/exd.14584. Epub 2022 May 11. No abstract available.
PubMed 35491738
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Cold Atmospheric Plasma Device to Treat Skin Disorders
- ClinicalTrials.gov ID
- NCT02759900
- Acronym / sponsor ID
- 20130084
- Conditions
- Actinic Keratosis, Acne/Rosacea, Verruca Plana, Tinea, Molluscum Contagiosum, Bowen's Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Skin Center Dermatology GroupIndustry (pharma, biotech, devices)
- Study start
- Jan 2016 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 3 May 2016 (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 study examines the efficacy of a non-thermal, atmospheric plasma device in the treatment of skin disorders
Detailed description
The study uses non-thermal atmospheric pressure plasma to treat target conditions. The patients are monitored at set intervals for efficacy and adverse effects using investigator's assessment and imaging techniques
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-thermal atmospheric plasma treatment | Experimental | Device: Non-thermal, atmospheric plasma to treat skin lesions and acneDevice treatment |
| Indirect non-thermal atmospheric plasma treatment | Experimental | Device: Indirect non-thermal, atmospheric plasma to treat hair loss and acneA compound of non-thermal atmospheric plasma and medium is used to treat the target by direct application or by on-site generation of the compound |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- diagnoses of target conditions
- ability to complete study protocol
Key exclusion criteria (1 listed)
- based on specific condition
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 |
|---|---|---|
| Non-thermal, atmospheric plasma to treat skin lesions and acneNon-thermal, atmospheric plasma treatment of affected area or lesions using a nanosecond dielectric barrier discharge plasma device | Device | Non-thermal atmospheric plasma treatment |
| Indirect non-thermal, atmospheric plasma to treat hair loss and acneA compound of non-thermal, atmospheric plasma and medium is delivered to or generated at the target area. Plasma is generated using either microsecond dielectric barrier discharge plasma device or PiezoBrush (a helium jet plasma). The medium is an aqueous alcohol solution | Device | Indirect non-thermal atmospheric plasma treatment |
Primary outcome
Clinical improvement
Time frame: 1-12 months
The outcome is the presence or lack of clinical improvement in the investigator's global assessment and reviewing photo-documentation as well as reflectance confocal microscopy study investigator's global assessment and reviewing photo-documentation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Derived from this study: PubMed 36302167Friedman PC, Fridman G, Fridman A. Cold atmospheric pressure plasma clears molluscum contagiosum. Exp Dermatol. 2023 Apr;32(4):562-563. doi: 10.1111/exd.14695. Epub 2022 Nov 3. No abstract available.
- Derived from this study: PubMed 35491738Malik S, Gill M, Fridman G, Fridman A, Friedman PC. Cold atmospheric plasma reduces demodex count on the face comparably to topical ivermectin, as measured by reflectance confocal microscopy. Exp Dermatol. 2022 Sep;31(9):1352-1354. doi: 10.1111/exd.14584. Epub 2022 May 11. No abstract available.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-thermal, atmospheric plasma to treat skin lesions and acne and Indirect non-thermal, atmospheric plasma to treat hair loss and acne in people with Actinic Keratosis and Acne/Rosacea, run by The Skin Center Dermatology Group 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 2 inclusion and 1 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 12 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement (time frame: 1-12 months). 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 NCT02759900, which also lists 2 linked publications.
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 12 Apr 2022.