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

• Sponsor: The Skin Center Dermatology Group (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05592548
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 5.9
• Patients Per Site Per Month: 1.7

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Rosacea, Papulopustular	Device: cold atmospheric plasma	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: split face studysplit face study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Jan 2, 2023
• Anticipated Primary Completion Date: May 31, 2023
• Anticipated Study Completion Date: Jun 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Efficacy - Investigator global assessment [6 weeks]

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

2. RosaQoL change [6 weeks]

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

3. Demodex count change [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 [6 weeks]

   Complex scoring system as described by Wilkin et al, J Am Acad Dermatol 2004;50:907-12

Secondary Outcome Measures

1. Tolerability - Incidence of Treatment-Emergent Adverse Events as assessed by patient review [6 weeks]

   patient reported adverse effects collected using questionnaires

2. Tolerability - pain as assessed by NRS scale [6 weeks]

   Pain assessment using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable"

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Skin Center Dermatology Group	New City	New York	United States	10956

Sponsors and Collaborators

• The Skin Center Dermatology Group

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Skin Center Dermatology Group
• ClinicalTrials.gov Identifier: NCT05592548
• Other Study ID Numbers: ROSACECAPRCM
• First Posted: Oct 24, 2022
• Last Update Posted: Oct 31, 2022
• Last Verified: Oct 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Rosacea

Study Results

No Results Posted as of Oct 31, 2022