Rosacea Treatment Using Non-thermal (Cold) Atmospheric Plasma Device

Study Overview
=================
Brief 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

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

Conditions
-----------------
Rosacea, Papulopustular

Intervention / Treatment
-----------------
* Device: cold atmospheric plasma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Papulopustular rosacea of the cheeks Ability to complete six weeks of twice-weekly treatments Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: split face study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study<br>Single arm study: split face treatment | Device: cold atmospheric plasma<br>* Cold atmospheric plasma will be generated on the skin surface using an electric device<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Pain assessment using a 0-10 scale, with zero meaning no pain and 10 meaning the worst pain imaginable | 6 weeks |