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CompletedNCT05592548Updated Dec 4, 2024

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

An interventional study of cold atmospheric plasma in Rosacea, Papulopustular, sponsored by The Skin Center Dermatology Group. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-04.

Sponsored by The Skin Center Dermatology Group · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Rosacea, Papulopustular

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Papulopustular rosacea of the cheeks
  • Ability to complete six weeks of twice-weekly treatments

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Experimental
    Study

    Single arm study: split face treatment

    Device: cold atmospheric plasma

Interventions

  • Devicecold atmospheric plasma

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

05

What researchers measure

Primary outcomes

  1. Efficacy - Investigator global assessment

    Rosacea improvement will be evaluated based on clinical photos (worsened, unchanged, mild improvement, substantial improvement, cleared)

    Time frame: 6 weeks

  2. RosaQoL change

    Rosacea Quality of Life tool: 5-point scale Ranging from 1 (no impact) to 5 (worst impact)

    Time frame: 6 weeks

  3. 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)

    Time frame: 6 weeks

  4. 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

    Time frame: 6 weeks

Secondary outcomes

  1. Tolerability - Incidence of Treatment-Emergent Adverse Events as assessed by patient review

    patient reported adverse effects collected using questionnaires

    Time frame: 6 weeks

  2. 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"

    Time frame: 6 weeks

06

Study locations

1 site
  • The Skin Center Dermatology Group
    New City, New York 10956, United States
07

References and documents

Publications

  • 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. PubMed 35491738 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT05592548
Lead sponsor
The Skin Center Dermatology Group
Responsible party
Sponsor
First posted
Oct 24, 2022
Start date
Jan 2, 2024
Primary completion
May 31, 2024
Completion
Jun 30, 2024
Last update
Dec 4, 2024

Study contacts

Peter Friedman, MD PhD
principal investigator · The Skin Center Dermatology Group

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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