Evaluation of Experimental Heat Patch
|ClinicalTrials.gov Identifier: NCT01841788|
Recruitment Status : Completed
First Posted : April 29, 2013
Last Update Posted : March 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Effects of Heat Tolerability Adhesiveness Dermal Irritation||Device: Thermal Adhesion Patch Device: Marketed Thermal Adhesion Patch Device: Placebo Patch||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Evaluation of Experimental and Commercial Air-Activated, Adhesive Backed Heat Patches|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
Experimental: Thermal Adhesion Patch
Group of subjects wearing the experimental patch for 8 hour study duration
Device: Thermal Adhesion Patch
Active Comparator: Marketed Thermal Adhesion Patch
Group of subjects wearing comparative predicate device for 8 hour study duration.
Device: Marketed Thermal Adhesion Patch
Other Name: ThermaCare Heat Wraps
Placebo Comparator: Placebo Patch
Group of subjects wearing the placebo patch for 8 hour study duration
Device: Placebo Patch
- Irritation Evaluation [ Time Frame: 8 hours ]A trained skin grader will apply a predetermined scale to the observed skin reactions in the test areas under light supplied by a 100-watt incandescent blue bulb.
- Adhesion Evaluation [ Time Frame: 8 Hours ]Adhesion will be evaluated to a predetermined scale when the subjects return for visit 3 after approximately 8 hours of wear time.
- Heat Intensity [ Time Frame: 8 hours ]Assessed using thermocouple sensors worn between the patch and subject's skin with readings taken every 15 minutes.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841788
|United States, Florida|
|Radiant Research, Inc.|
|Pinellas Park, Florida, United States, 33781|
|Principal Investigator:||Daniel J Hogan, MD||Radiant Research|