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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study | Experimental | Single arm study: split face treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cold atmospheric plasma | Device | Cold atmospheric plasma will be generated on the skin surface using an electric device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy - Investigator global assessment | Rosacea improvement will be evaluated based on clinical photos (worsened, unchanged, mild improvement, substantial improvement, cleared) | 6 weeks |
| RosaQoL change | Rosacea Quality of Life tool: 5-point scale Ranging from 1 (no impact) to 5 (worst impact) | 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) | 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 | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability - Incidence of Treatment-Emergent Adverse Events as assessed by patient review | patient reported adverse effects collected using questionnaires | 6 weeks |
| Tolerability - pain as assessed by NRS scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Friedman, MD PhD | The Skin Center Dermatology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Skin Center Dermatology Group | New City | New York | 10956 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35491738 | Result | 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. |
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| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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split face study
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Pain assessment using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
| 6 weeks |