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

NCT05592548 | Completed

• 1 other identifier: ROSACECAPRCM
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Conditions

Rosacea, Papulopustular

Outcome Measures

Primary Outcomes (4)

• Efficacy - Investigator global assessment

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

  6 weeks

• RosaQoL change

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

  6 weeks

• 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)

  6 weeks

• 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

  6 weeks

Secondary Outcomes (2)

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

  6 weeks

• Tolerability - pain as assessed by NRS scale

  6 weeks

Study Arms (1)

Study

EXPERIMENTAL

Single arm study: split face treatment

Device: cold atmospheric plasma

Interventions

cold atmospheric plasma DEVICE

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

Study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Skin Center Dermatology Group: lead

Study Sites (1)

The Skin Center Dermatology Group

New City, New York, 10956, United States

Location

Related Publications (1)

• 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.

  PMID: 35491738 BACKGROUND

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Peter Friedman, MD PhD

  The Skin Center Dermatology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: split face study

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: October 24, 2022
• Study Start: January 2, 2024
• Primary Completion: May 31, 2024
• Study Completion: June 30, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)