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OpenTrials
Completed

NCT Number: NCT05592548

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

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

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Key information

Conditions

Rosacea, Papulopustular Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Skin Center Dermatology Group

New City, New York, 10956, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cold Atmospheric Plasma

Device

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

Primary outcomes

  1. Efficacy - Investigator global assessment

    Time frame: 6 weeks

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

  2. RosaQoL change

    Time frame: 6 weeks

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

  3. 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)

  4. 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

Secondary outcomes

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

    Time frame: 6 weeks

    patient reported adverse effects collected using questionnaires

  2. 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"

Sponsors and collaborators

Lead sponsor

The Skin Center Dermatology Group

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 24, 2022
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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