Back to resultsRosacea Treatment Using Non-thermal (Cold) Atmospheric Plasma Device
Primary Purpose
Rosacea, Papulopustular
Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cold atmospheric plasma
Sponsored by
About this trial
This is an interventional treatment trial for Rosacea, Papulopustular
Eligibility Criteria
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
Sites / Locations
- The Skin Center Dermatology Group
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study
Arm Description
Single arm study: split face treatment
Outcomes
Primary Outcome Measures
Efficacy - Investigator global assessment
Rosacea improvement will be evaluated based on clinical photos (worsened, unchanged, mild improvement, substantial improvement, cleared)
RosaQoL change
Rosacea Quality of Life tool: 5-point scale Ranging from 1 (no impact) to 5 (worst impact)
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)
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
Secondary Outcome Measures
Tolerability - Incidence of Treatment-Emergent Adverse Events as assessed by patient review
patient reported adverse effects collected using questionnaires
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"
Full Information
NCT ID
NCT05592548
First Posted
October 18, 2022
Last Updated
April 10, 2023
Sponsor
The Skin Center Dermatology Group
1. Study Identification
Unique Protocol Identification Number
NCT05592548
Brief Title
Rosacea Treatment Using Non-thermal (Cold) Atmospheric Plasma Device
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Suspended
Why Stopped
Reevaluating protocol based on preliminary data
Study Start Date
January 2, 2024 (Anticipated)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Skin Center Dermatology Group
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea, Papulopustular
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
split face study
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study
Arm Type
Experimental
Arm Description
Single arm study: split face treatment
Intervention Type
Device
Intervention Name(s)
cold atmospheric plasma
Intervention Description
Cold atmospheric plasma will be generated on the skin surface using an electric device
Primary Outcome Measure Information:
Title
Efficacy - Investigator global assessment
Description
Rosacea improvement will be evaluated based on clinical photos (worsened, unchanged, mild improvement, substantial improvement, cleared)
Time Frame
6 weeks
Title
RosaQoL change
Description
Rosacea Quality of Life tool: 5-point scale Ranging from 1 (no impact) to 5 (worst impact)
Time Frame
6 weeks
Title
Demodex count change
Description
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)
Time Frame
6 weeks
Title
Efficacy - National Rosace Society Expert Committee grading system
Description
Complex scoring system as described by Wilkin et al, J Am Acad Dermatol 2004;50:907-12
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Tolerability - Incidence of Treatment-Emergent Adverse Events as assessed by patient review
Description
patient reported adverse effects collected using questionnaires
Time Frame
6 weeks
Title
Tolerability - pain as assessed by NRS scale
Description
Pain assessment using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Friedman, MD PhD
Organizational Affiliation
The Skin Center Dermatology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Skin Center Dermatology Group
City
New City
State/Province
New York
ZIP/Postal Code
10956
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35491738
Citation
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.
Results Reference
result
Learn more about this trial
Rosacea Treatment Using Non-thermal (Cold) Atmospheric Plasma Device
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