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

December 1, 2024 updated by: The Skin Center Dermatology Group

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New City, New York, United States, 10956
        • The Skin Center Dermatology Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy - Investigator global assessment
Time Frame: 6 weeks
Rosacea improvement will be evaluated based on clinical photos (worsened, unchanged, mild improvement, substantial improvement, cleared)
6 weeks
RosaQoL change
Time Frame: 6 weeks
Rosacea Quality of Life tool: 5-point scale Ranging from 1 (no impact) to 5 (worst impact)
6 weeks
Demodex count change
Time Frame: 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)
6 weeks
Efficacy - National Rosace Society Expert Committee grading system
Time Frame: 6 weeks
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
Time Frame: 6 weeks
patient reported adverse effects collected using questionnaires
6 weeks
Tolerability - pain as assessed by NRS scale
Time Frame: 6 weeks
Pain assessment using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Skin Center Dermatology Group

Investigators

  • Principal Investigator: Peter Friedman, MD PhD, The Skin Center Dermatology Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2024

Primary Completion (Actual)

May 31, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

October 18, 2022

First Submitted That Met QC Criteria

October 20, 2022

First Posted (Actual)

October 24, 2022

Study Record Updates

Last Update Posted (Estimated)

December 4, 2024

Last Update Submitted That Met QC Criteria

December 1, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROSACECAPRCM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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