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

Chattem, Inc.1 site in 1 country157 target enrollmentOctober 2012

ConditionsEffects of Heat Tolerability Adhesiveness Dermal Irritation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Effects of Heat
Sponsor: Chattem, Inc.
Enrollment: 157
Locations: 1
Primary Endpoint: Irritation Evaluation
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To assess the safety and tolerability for the extended wear of an experimental air-activated self adhesive patch.

Registry

clinicaltrials.gov

Start Date

October 2012

End Date

December 2012

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chattem, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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
•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;

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;

Outcomes

Primary Outcomes

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.