Rosacea, PapulopustularNCT05592548
Rosacea Treatment Using Non-thermal (Cold) Atmospheric Plasma Device
A study testing cold atmospheric plasma in people with Rosacea, Papulopustular, run by The Skin Center Dermatology Group at 1 site in United States.
Trial summary
10-13 patients will be enrolled to receive split face treatment: the control side will be treated with metronidazole cream, the intervention side will be treated with a cold atmospheric plasma device Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rosacea, Papulopustular
- What is being tested?
- cold atmospheric plasma
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2024to 30 Jun 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Papulopustular rosacea of the cheeks
- Ability to complete six weeks of twice-weekly treatments
Who cannot join
- substantial asymmetry of disease distribution
- previous failure of topical ivermectin treatment
- presence of any other facial dermatoses
- presence of any photosensitizing disorders
- systemic tetracycline, systemic or topical ivermectin treatment within 6 weeks of start date
- current or within prior 3 months treatment with systemic immune-suppressive medication
Trial locations and contacts
1 site in 1 country.
United States1 site
The Skin Center Dermatology Group
New City, New York, 10956
About this study
Official title: Open Label Split Face Pilot Study to Assess the Safety and Efficacy of Cold Atmospheric Plasma (Non-thermal Plasma) for the Treatment of Rosacea
10-13 patients will be enrolled to receive split face treatment: the control side will be treated with metronidazole cream, the intervention side will be treated with a cold atmospheric plasma device
- Conditions
- Rosacea, Papulopustular
- Being tested
- cold atmospheric plasma
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold atmospheric plasmaDevice
Cold atmospheric plasma will be generated on the skin surface using an electric device
| Study group | Role | What they receive |
|---|---|---|
| Study | Experimental | Single arm study: split face treatment Receives: Device: cold atmospheric plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy - Investigator global assessment
Rosacea improvement will be evaluated based on clinical photos (worsened, unchanged, mild improvement, substantial improvement, cleared)
Measured: 6 weeks
RosaQoL change
Rosacea Quality of Life tool: 5-point scale Ranging from 1 (no impact) to 5 (worst impact)
Measured: 6 weeks
Demodex count change
Change in demodex folliculorum mite density, measured by Reflectance Confocal Microscopy )number of follicles with mite, total number of mites in measured area, number of mites per follicle)
Measured: 6 weeks
Efficacy - National Rosace Society Expert Committee grading system
Complex scoring system as described by Wilkin et al, J Am Acad Dermatol 2004;50:907-12
Measured: 6 weeks
Secondary outcomes (2)
Tolerability - Incidence of Treatment-Emergent Adverse Events as assessed by patient review
patient reported adverse effects collected using questionnaires
Measured: 6 weeks
Tolerability - pain as assessed by NRS scale
Pain assessment using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start2 Jan 2024
- Primary completion31 May 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rosacea, PapulopustularStudies 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
- Model description
- split face study
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Skin Center Dermatology Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Friedman, MD PhD, Principal investigator, The Skin Center Dermatology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592548
- Sponsor's protocol ID
- ROSACECAPRCM
- Status last verified
- Dec 2024
- First submitted
- 18 Oct 2022
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Malik 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 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Split Face Pilot Study to Assess the Safety and Efficacy of Cold Atmospheric Plasma (Non-thermal Plasma) for the Treatment of Rosacea
- ClinicalTrials.gov ID
- NCT05592548
- Acronym / sponsor ID
- ROSACECAPRCM
- Conditions
- Rosacea, Papulopustular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- The Skin Center Dermatology GroupIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 24 Oct 2022 (actual)
- 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.
10-13 patients will be enrolled to receive split face treatment: the control side will be treated with metronidazole cream, the intervention side will be treated with a cold atmospheric plasma device
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- split face study
| Arm | Type | Receives |
|---|---|---|
| Study | Experimental | Device: cold atmospheric plasmaSingle arm study: split face treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Papulopustular rosacea of the cheeks
- Ability to complete six weeks of twice-weekly treatments
Key exclusion criteria (6 listed)
- substantial asymmetry of disease distribution
- previous failure of topical ivermectin treatment
- presence of any other facial dermatoses
- presence of any photosensitizing disorders
- systemic tetracycline, systemic or topical ivermectin treatment within 6 weeks of start date
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 |
|---|---|---|
| cold atmospheric plasmaCold atmospheric plasma will be generated on the skin surface using an electric device | Device | Study |
Primary outcome
Efficacy - Investigator global assessment
Time frame: 6 weeks
Rosacea improvement will be evaluated based on clinical photos (worsened, unchanged, mild improvement, substantial improvement, cleared)
RosaQoL change
Time frame: 6 weeks
Rosacea Quality of Life tool: 5-point scale Ranging from 1 (no impact) to 5 (worst impact)
Demodex count change
Time frame: 6 weeks
Change in demodex folliculorum mite density, measured by Reflectance Confocal Microscopy )number of follicles with mite, total number of mites in measured area, number of mites per follicle)
Efficacy - National Rosace Society Expert Committee grading system
Time frame: 6 weeks
Complex scoring system as described by Wilkin et al, J Am Acad Dermatol 2004;50:907-12
2 secondary outcomes
Tolerability - Incidence of Treatment-Emergent Adverse Events as assessed by patient review
Time frame: 6 weeks
Tolerability - pain as assessed by NRS scale
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Results publication: 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.
- Individual participant dataSharing planned: No
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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.
Peter Friedman, MD PhD principal investigator
The Skin Center Dermatology Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cold atmospheric plasma in people with Rosacea, Papulopustular, 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 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 4 Dec 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy - Investigator global assessment (time frame: 6 weeks). The study lists 4 primary outcomes in all. 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 NCT05592548, which also lists 1 linked publication.
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 Dec 2024.