Safety of Pulsing Heating Device Use on the Skin

Not Applicable

• Conditions: Pain

• Registration Number: NCT05427877
• Lead Sponsor: Integrative Skin Science and Research

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-06
• Study Start: 2022-06
• Study First Submitted: 2022-06-15
• Study First Submitted QC: 2022-06-19
• Last Update Submitted: 2022-06-19
• Study First Posted: 2022-06-22
• Last Update Posted: 2022-06-22
• Primary Completion: 2022-12
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Integrative Skin Science and Research; 🇺🇸 Sacramento, California, United States