Safety of Pulsing Heating Device Use on the Skin

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

Study Overview

• Status: Not yet recruiting
• Conditions: Pain
• Intervention / Treatment: Device: Heating device (Heatwave Technology)

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Maloh, ND; Phone Number: 9167502463; Email: jessica@integrativeskinresearch.com

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95819
      • Integrative Skin Science and Research
      • Contact: Jessica Maloh, ND; Phone Number: 916-750-2463; Email: jessica@integrativeskinresearch.com
      • Principal Investigator: Jessica Maloh, ND
      • Sub-Investigator: Raja Sivamani, MD MS AP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.; Other Names: Soovu heating devices (Heatwave Technology)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Integrative Skin Science and Research
• Collaborators: Soovu Labs Inc.

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: June 15, 2022
• First Submitted That Met QC Criteria: June 19, 2022
• First Posted (Actual): June 22, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2022
• Last Update Submitted That Met QC Criteria: June 19, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: Soovu_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No