A Comparative Study to Evaluate Two Air-Activated Adhesive Backed Heat Patches

August 10, 2020 updated by: Chattem, Inc.

A Randomized, Open-Label, Comparative Study To Evaluate the Adhesion and Temperature Properties of Two Air-Activated, Adhesive Backed Heat Patches in Healthy Volunteers

A disposable, air-activated, adhesive backed heat patch is being evaluated.

Study terminated -O subjects.

Study Overview

Status

Status

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

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.

Detailed Description

Study Protocol Terminated--0 subjects

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.
200

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
    • Arizona
      • Chandler, Arizona, United States, 85224
        • 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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects who complete an appropriately administered informed consent process that includes signing the IRB-approved consent form;
  • subjects 18-75 years old of each sex;
  • are of any skin type or race, providing the skin pigmentation will allow discernment of erythema;
  • subjects who are in good general health and free of any disease state or physical condition;
  • subjects who are willing and able to have the study products applied as directed, and comply with study instructions;
  • subjects must be willing to restrict their activity for the 8 hour patch wear time so that patches and thermocouples do not come loose;
  • subjects must be willing to wear a pouch containing the thermologger and thermocouple wiring for the entire 8 hours;
  • subjects who are 55 years or older agree to wear a t-shirt provided by the site for the entire 8 hour patch wear time.

Exclusion Criteria:

  • Subjects who are pregnant or nursing;
  • subjects with excessive hair at the application site, scar tissue, tattoo or coloration that would interfere with the placement of the study product or the skin assessment;
  • subjects with diabetes or poor circulation or 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;
  • subjects unable to feel pain or heat (e.g., subjects with neuropathy);
  • subjects with active dermatitis (including sunburn) in the treatment area or other visible dermatological disease which, in the investigator's opinion, might interfere with the response to the study products or interfere with the skin assessments associated with the study products;
  • have history of significant dermatologic cancers or neoplasms in the treatment area;
  • subjects who have used topical dermatological products in the application area within 24 hours prior to anticipated study product application;
  • subjects using a concomitant medication that, in the investigator's opinion, could interfere with the interpretation of the study results. Examples of such drugs include vasoactive (constrictor or dilator) medications, prescription or OTC, that could modulate blood flow, within 24 hours prior to or during the application of study products, including nitroglycerin, non-steroidal anti-inflammatory products (NSAIDs, e.g., ibuprofen, aspirin (<=81 mg/day is acceptable)), topical corticosteroids and OTC cough/cold products including antihistamines and/or either phenylpropanolamine or phentolamine;
  • subjects who have used systemic steroids (i.e., oral, IV, IM or intra-articular) 30 days prior to the application of test articles (intranasal/inhaled steroids are acceptable);
  • subjects who have received an investigational medication or device within 30 days prior to enrollment into this study;
  • subjects who have a history of sensitivity to any of the study products or adhesion materials;
  • subjects who are currently participating in an investigational study;
  • subjects who are known to be noncompliant or are unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, product dependency, mental incapacity) in the opinion of the investigator.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

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.
Experimental: Air Activated Heat Patch
The experimental air activated heat patch will be worn by the subjects for 8 hours.
Device: Thermal Adhesion Patch
Other Names:
  • Marketed ThermaCare Thermal Adhesion Patch
Active Comparator: Marketed ThermaCare Air Activated Heat Patch
The marketed air activated heat patch will be worn by the subjects for 8 hours.
Device: Thermal Adhesion Patch
Other Names:
  • Marketed ThermaCare Thermal Adhesion 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
Heat Intensity
Time Frame: 8 hours
Assessed using sensors.
8 hours

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: 8 hours
Adhesion will be evaluated by visual assessment.
8 hours
Irritation Evaluation
Time Frame: 8 hours
At the conclusion of the study and upon removal of the heat patch the application area will be observed by a trained skin grader for visual signs of irritation.
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: Albert Q. Tejada, MD, Radiant Research, Inc.

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.
March 1, 2014

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.
April 1, 2014

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.
May 1, 2014

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).
March 4, 2014

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.
March 5, 2014

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.
March 6, 2014

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.
August 12, 2020

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.
August 10, 2020

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.
August 1, 2020

More Information

Terms related to this study

Keywords

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.
  • 2014003

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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