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

March 15, 2017 updated by: Chattem, Inc.
To assess the safety and tolerability for the extended wear of an experimental air-activated self adhesive patch.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
157

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Pinellas Park, Florida, United States, 33781
        • Radiant Research, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
7 days - 8 hours each day

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
after 8 hours

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Heat Intensity
Time Frame: 8 hours
Assessed using thermocouple sensors worn between the patch and subject's skin with readings taken every 15 minutes.
8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chattem, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniel J Hogan, MD, Radiant Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2012007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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