Evaluation of Experimental and Commercial Air-Activated, Adhesive Backed Heat Patches
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01841801|
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 Adhesive Patch Device: Marketed Thermal Adhesive Patch Device: Placebo Patch||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||157 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 :||December 2012|
|Actual Study Completion Date :||December 2012|
Active Comparator: Marketed Thermal Adhesive Patch
Group of subjects wearing comparative predicate device for 8 hours daily for 7 days.
Device: Marketed Thermal Adhesive Patch
Other Name: ThermaCare Heat Wraps
Experimental: Thermal Adhesive Patch
Group of subjects wearing the experimental patch for 8 hours daily for 7 days.
Device: Thermal Adhesive Patch
Placebo Comparator: Placebo Patch
Group of subjects wearing the placebo patch for 8 hours daily for 7 days.
Device: Placebo Patch
- Irritation Evaluation [ Time Frame: 7 days - 8 hours each day ]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: after 8 hours ]Adhesion will be evaluated to a predetermined scale when the subjects return for visits; 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01841801
|United States, Florida|
|Radiant Research, Inc|
|Pinellas Park, Florida, United States, 33781|
|Principal Investigator:||Daniel J Hogan, MD||Radiant Research|