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

Open Label Split Face Pilot Study to Assess the Safety and Efficacy of Cold Atmospheric Plasma (non-thermal Plasma) for the Treatment of Rosacea

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05592548

Enrollment

Registered

2022-10-24

Start date

2024-01-02

Completion date

2024-06-30

Last updated

2024-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rosacea, Papulopustular

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

Interventions

DEVICEcold atmospheric plasma

Cold atmospheric plasma will be generated on the skin surface using an electric device

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

split face study

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026