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

Rosacea, Papulopustular Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05592548
• Other study ID #: ROSACECAPRCM
• Status: Suspended
• Phase: N/A
• Start date: January 2, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2022
• Source: The Skin Center Dermatology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 10
• Est. completion date: June 30, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rosacea
• Rosacea, Papulopustular

Intervention

Device:
• cold atmospheric plasma
Cold atmospheric plasma will be generated on the skin surface using an electric device

Locations

Country	Name	City	State
United States	The Skin Center Dermatology Group	New City	New York

Sponsors (1)

Lead Sponsor	Collaborator
The Skin Center Dermatology Group

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy - Investigator global assessment	Rosacea improvement will be evaluated based on clinical photos (worsened, unchanged, mild improvement, substantial improvement, cleared)	6 weeks
Primary	RosaQoL change	Rosacea Quality of Life tool: 5-point scale Ranging from 1 (no impact) to 5 (worst impact)	6 weeks
Primary	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
Primary	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	Tolerability - Incidence of Treatment-Emergent Adverse Events as assessed by patient review	patient reported adverse effects collected using questionnaires	6 weeks
Secondary	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