Evaluation of Experimental and Commercial Air-Activated, Adhesive Backed Heat Patches

Exclusion Criteria

• •Participants with known skin sensitivity to adhesion products;
• •Participants with any skin abnormality likely to be aggravated by the study material such as dermatological disease or infection, rash, atrophic, fragile, or abnormally dry skin, cuts or abrasions at the treatment site;
• •Participants who are pregnant or nursing, oral interview only;
• •Participants with diabetes or poor circulation;
• •Participants unable to tolerate conditions of protocol;
• •Participants viewed by the investigator as not being suitable for the study;
• •Participants who have had active skin cancer including basal cell carcinoma, or other cancer within one year;
• •Participants who are currently participating in another clinical trial;
• •Participants who routinely use anti-inflammatory medications (within 5 days of study start (81mg aspirin is okay)) or immunosuppressive or antihistamine medications within 3 weeks prior to study start (steroid nose/eye drops are ok);
• •Participants who currently use allergy injections;
• •Participants with history of severe asthma;
• •Participants with active or uncontrolled immunologic disorders i.e. AIDS, HIV positive, systemic lupus erythematosus, rheumatoid arthritis;
• •Participants with uncontrolled thyroid disease;
• •Participants who have any clinically significant chronic illness which could place the subject at increased risk during participation or result in inappropriate dermal response during the study;
• •Participants who have used topical medications at the test sites within the past 14 days;
• •Participants who have lower midline abdominal pinnicula which may interfere with heat patch/wrap application and or evaluation;
• •Participants who have a pacemaker, defibrillator or other implantable medical device;
• •Participants who have allergies to latex, polyethylene, polypropylene, nickel, chromium or aluminum.