Evaluation of Experimental and Commercial Air-Activated, Adhesive Backed Heat Patches (NCT01841801) | Clinical Trial Compass
CompletedNot Applicable
Evaluation of Experimental and Commercial Air-Activated, Adhesive Backed Heat Patches
United States157 participantsStarted 2012-10
Plain-language summary
To assess the safety and tolerability for the extended wear of an experimental air-activated self adhesive patch.
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 to 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;
* back region must be free from excessive hair, cuts, tatoos, or other aberrations;
* must understand and sign Informed Consent;
* must be considered dependable and able to follow directions;
* Participants assigned to the thermocouples must be willing to restrict their activity for the 8 hour patch wear time so that the thermocouples do not come loose;
* Participants assigned to the thermocouples 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 15. If the items are not returned subject may be invoiced for the value of the unit;
* must be willing to not wear any topical products such as lotions, sunscreens, etc. in the test area while participating in 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 each day with a CLEAN back;
* Participants who are 55 years of age and older, agree to supply a t-shirt to wear at visit two that can be marked on with a marker, and to use that t-shirt or supply others at the morni…