An interventional study of cold atmospheric plasma in Rosacea, Papulopustular, sponsored by The Skin Center Dermatology Group. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-04.
Sponsored by The Skin Center Dermatology Group · Not applicable, Interventional, and Treatment
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
233 studies on the registry are indexed under Rosacea; 23 are open to participants now.
This study's enrollment of 5 is below the median of 61 across 200 interventional studies indexed under Rosacea.
Browse Rosacea studies →The Skin Center Dermatology Group is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Single arm study: split face treatment
Device: cold atmospheric plasma
Cold atmospheric plasma will be generated on the skin surface using an electric device
Efficacy - Investigator global assessment
Rosacea improvement will be evaluated based on clinical photos (worsened, unchanged, mild improvement, substantial improvement, cleared)
Time frame: 6 weeks
RosaQoL change
Rosacea Quality of Life tool: 5-point scale Ranging from 1 (no impact) to 5 (worst impact)
Time frame: 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)
Time frame: 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
Time frame: 6 weeks
Tolerability - Incidence of Treatment-Emergent Adverse Events as assessed by patient review
patient reported adverse effects collected using questionnaires
Time frame: 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"
Time frame: 6 weeks
Plan to share: No
Ran from Jan 2024 to primary completion in May 2024, 4 months.
Of 42 interventional studies with no phase under Rosacea, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 29. This study's 4 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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The Skin Center Dermatology Group