Cold Atmospheric Plasma Device Extension Study
Patients between 4-21 years of age with at least one wart or molluscum lesion are eligible to participate in this study. The duration of the study is a minimum of 4 weeks with the maximum duration of monthly treatments for one year, depending on lesion clearance. The number of lesions will be chosen by the dermatologist. Patients who opt to participate will receive non-thermal, or cold, atmospheric plasma to treat all lesions selected. Safety profile as well as changes in size, pain and appearance will be measured. Photographs and dermatologist impressions will be used to measure treatment response.
Conditions:
🦠 Verruca Vulgaris 🦠 Molluscum Contagiosum
🗓️ Study Start (Actual) 18 September 2023
🗓️ Primary Completion (Estimated) 1 July 2024
✅ Study Completion (Estimated) 1 August 2024
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE3
Locations:
📍 Charleston, South Carolina, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * All patients from 4-21 years old with at least 1 lesion of vercurra or molluscum.
    • * Willingness of the participant and their guardian to provide consent when applicable.

    Exclusion Criteria:

    • * Unwillingness to participate in the study
    • * Received any treatment on the lesion in the past month determined by review of their medical record
    • * Immunodeficiency determined by review of their medical record.
    • * Adverse response to prior treatments determined by review of medical record.
    • * Signs of self-resolution determined by study team members.
    • * Conditions that lead to excessive scarring determined by study team members.
    • * Face and genital lesions determined by study team members.
Ages Eligible for Study: 4 Years to 21 Years (CHILD, ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 30 June 2023
  • First Submitted that Met QC Criteria 30 June 2023
  • First Posted 10 July 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 17 October 2023
  • Last Update Posted 19 October 2023
  • Last Verified October 2023