Safety of Pulsing Heating Device Use on the Skin

Overview

We hope to assess the safety of a recurrent heating device for pain relief.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2022

Interventions

  • Device: Heating device (Heatwave Technology)
    • Heating devices will be applied to the trunk and extremities of the body during the first study visit. During each heating cycle, the temperature will increase quickly from room temperature to a high of 45C and then cycle back down. Each heating cycle is 30 minutes with a 3 minute cool down period where no heat is applied. The maximum temperature used in this study is 45 degrees C (113 degrees F). There will be a total of 3 heating cycles at the visit.

Arms, Groups and Cohorts

  • Experimental: Heating Device Application
    • Heating devices will be applied to the trunk and extremities of the body.

Clinical Trial Outcome Measures

Primary Measures

  • Pain – Visual Analog Scale
    • Time Frame: 100 minutes
    • Subjective reporting of pain with 10 point pain scale 0= no pain 10= very severe pain
  • Erythema (skin redness)
    • Time Frame: 100 minutes
    • Measured with skin colorimeter
  • Post-inflammatory hyperpigmentation
    • Time Frame: 100 minutes
    • Measured with skin colorimeter

Secondary Measures

  • Mood and Anxiety Assessment
    • Time Frame: 100 minutes
    • Survey based measure using Likert scale responses
  • Mood and Anxiety Assessment
    • Time Frame: 1 week
    • Survey based measure using Likert scale responses
  • Pain – Visual Analog Scale
    • Time Frame: 1 week
    • Subjective reporting of pain with 10 point pain scale 0= no pain 10= very severe pain
  • Erythema (skin redness)
    • Time Frame: 1 week
    • Measured with skin colorimeter
  • Post-inflammatory hyperpigmentation
    • Time Frame: 1 week
    • Measured with skin colorimeter

Participating in This Clinical Trial

Inclusion Criteria

  • Individuals in good general health. – No known medical conditions that, in the investigator's opinion, may interfere with study participation. – Subjects 18 year of age and older. Exclusion Criteria:

  • Individuals who have history of acute or chronic disease that would likely interfere with or increase the risk on study participation at the discretion of the investigator. – Individuals with peripheral neuropathy or a neuropathic condition that would alter their ability to sense pain. – Individuals with clinically significant unstable medical disorders that would disqualify the participant at the discretion of the investigator. – Individuals who have history of a psychological illness or condition that would interfere with their ability to understand and follow the requirements of the study at the discretion of the investigator. – Women who are pregnant.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Integrative Skin Science and Research
  • Collaborator
    • Soovu Labs Inc.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jessica Maloh, ND, Prinicipal Investigator – Integrative Skin Science and Research
  • Overall Contact(s)
    • Jessica Maloh, ND, 9167502463, jessica@integrativeskinresearch.com

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