Safety of Pulsing Heating Device Use on the Skin
1 other identifier
interventional
25
1 country
1
Brief Summary
We hope to assess the safety of a recurrent heating device for pain relief.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable pain
Started Jun 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2022
CompletedFirst Submitted
Initial submission to the registry
June 15, 2022
CompletedFirst Posted
Study publicly available on registry
June 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedJune 22, 2022
June 1, 2022
6 months
June 15, 2022
June 19, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (5)
Mood and Anxiety Assessment
100 minutes
Mood and Anxiety Assessment
1 week
Pain - Visual Analog Scale
1 week
Erythema (skin redness)
1 week
Post-inflammatory hyperpigmentation
1 week
Study Arms (1)
Heating Device Application
EXPERIMENTALHeating devices will be applied to the trunk and extremities of the body.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Integrative Skin Science and Researchlead
- Soovu Labs Inc.collaborator
Study Sites (1)
Integrative Skin Science and Research
Sacramento, California, 95819, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prinicipal Investigator
Study Record Dates
First Submitted
June 15, 2022
First Posted
June 22, 2022
Study Start
June 1, 2022
Primary Completion
December 1, 2022
Study Completion
June 1, 2023
Last Updated
June 22, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share