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

NCT ID: NCT05592548

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-02

Study Completion Date

2024-06-30

Brief Summary

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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

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Conditions

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Rosacea, Papulopustular

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

split face study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study

Single arm study: split face treatment

Group Type EXPERIMENTAL

cold atmospheric plasma

Intervention Type DEVICE

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

Interventions

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cold atmospheric plasma

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Skin Center Dermatology Group

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Friedman, MD PhD

Role: PRINCIPAL_INVESTIGATOR

The Skin Center Dermatology Group

Locations

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The Skin Center Dermatology Group

New City, New York, United States

Site Status

Countries

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United States

References

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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. Epub 2022 May 11. No abstract available.

Reference Type BACKGROUND
PMID: 35491738 (View on PubMed)

Other Identifiers

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ROSACECAPRCM

Identifier Type: -

Identifier Source: org_study_id