Safety of Pulsing Heating Device Use on the Skin

Pain Clinical Trial

Official title:

Safety of Pulsing Heating Device Use on the Skin

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05427877
• Other study ID #: Soovu_01
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2022
• Est. completion date: June 2023

Study information

• Verified date: June 2022
• Source: Integrative Skin Science and Research
• Contact: Jessica Maloh, ND
• Phone: 9167502463
• Email: jessica[@]integrativeskinresearch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: June 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Integrative Skin Science and Research	Sacramento	California

Sponsors (2)

Lead Sponsor	Collaborator
Integrative Skin Science and Research	Soovu Labs Inc.

Country where clinical trial is conducted

United States, 

Outcome

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