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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
Sponsor:
Information provided by (Responsible Party):
Chattem, Inc.

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

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 157 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
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

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Heat Intensity [ Time Frame: 8 hours ]
    Assessed using thermocouple sensors worn between the patch and subject's skin with readings taken every 15 minutes.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 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 morning visits (visits 4, 6, 8, 10, 12, 14).

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.

Information from the National Library of Medicine

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


Locations
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United States, Florida
Radiant Research, Inc
Pinellas Park, Florida, United States, 33781
Sponsors and Collaborators
Chattem, Inc.
Investigators
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Principal Investigator: Daniel J Hogan, MD Radiant Research

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Responsible Party: Chattem, Inc.
ClinicalTrials.gov Identifier: NCT01841801    
Other Study ID Numbers: 2012007
First Posted: April 29, 2013    Key Record Dates
Last Update Posted: March 17, 2017
Last Verified: April 2013
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No