Evaluation of Experimental Heat Patch (NCT01841788) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Experimental Heat Patch
United States40 participantsStarted 2012-10
Plain-language summary
A disposable, air-activated, adhesive backed heat patch is being developed to provide temporary relief from minor muscular ache and joint pains associated with overexertion strains and sprains as well as minor pain associated with arthritis. The aim of the study is to determine the safety and tolerability of the patch during normal wear conditions.
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants are 18-70 years of age;
* must be in general good health;
* must have absence of any visible disease that might be confused with a skin reaction to the test material;
* Participant's back region must be free of excessive hair, cuts, tattoos, or other aberrations;
* must understand and sign Informed Consent;
* must be considered dependable and able to follow directions;
* must be willing to restrict their activity for the 8 hour patch wear time so that the patches/thermocouples do not come loose;
* must be willing to wear a pouch containing the thermostat and thermocouple wiring for the entire 8 hour period and to return all study supplies to the site at Visit 3. If the items are not returned subject may be invoiced for the value of the unit;
* must be willing not to use any topical products such as lotions, sunscreens, etc. in the test area while participating on the study;
* must agree to use an adequate means of birth control which include: abstinence, partner vasectomy, Intrauterine Device, hormonal implant devices/injections, regular use of birth control pills, birth control patches or condoms with a spermicidal agent;
* Participants are willing to come in with a CLEAN back;
* Participants who are 55 years of age or older, agree to supply a t-shirt to wear at visit two that can be marked on with a marker.
Exclusion Criteria:
* Participants with known skin sensitivity to adhesion products;
* Participants with any skin abnormality likel…