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

Not Applicable

Completed

• Conditions: Rosacea, Papulopustular

• Registration Number: NCT05592548
• Lead Sponsor: The Skin Center Dermatology Group

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-10-20
• Study First Posted: 2022-10-24
• Study Start: 2024-01-02
• Primary Completion: 2024-05-31
• Study Completion: 2024-06-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-01
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Efficacy - Investigator global assessment	6 weeks	Rosacea improvement will be evaluated based on clinical photos (worsened, unchanged, mild improvement, substantial improvement, cleared)
RosaQoL change	6 weeks	Rosacea Quality of Life tool: 5-point scale Ranging from 1 (no impact) to 5 (worst impact)
Demodex count change	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	6 weeks	Complex scoring system as described by Wilkin et al, J Am Acad Dermatol 2004;50:907-12

Secondary Outcome Measures

Name	Time	Method
Tolerability - Incidence of Treatment-Emergent Adverse Events as assessed by patient review	6 weeks	patient reported adverse effects collected using questionnaires
Tolerability - pain as assessed by NRS scale	6 weeks	Pain assessment using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

Trial Locations

Locations (1)

The Skin Center Dermatology Group; 🇺🇸 New City, New York, United States