Investigational Air-Activated Adhesive-Backed Heat Patch (3-Cell)

A Randomized, Open-Label Study to Evaluate the Temperature Profile and Adhesion of an Air-Activated Adhesive-Backed Heat Patch in Healthy Volunteers

This is an open-label study. A total of approximately 60 subjects will be randomly assigned to receive either the heat patch (30 subjects) with a temperature probe/skin reference probe or a heat patch (30 subjects) alone. The study will consist of 2 visits.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: Investigational Air-Activated Adhesive-Backed Heat Patch (3-Cell); Other: Temperature Probe

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • Wilkins Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects who complete an appropriately administered informed consent process that includes signing the consent form.
• Subjects 18-75 years old of either sex.
• Are of any skin type or race, providing the skin pigmentation will allow discernment of erythema;
• Subjects who are in good general health.
• Subjects who are willing and able to have the test products applied as directed, and comply with study instructions.
• Participants must be willing to restrict their activity for the 8 hour patch wear time.
• All participants agree to wear a t-shirt provided by the site for the entire 8 hour patch wear time.

Exclusion Criteria:

• Subjects who have a history of sensitivity to any of the test products or adhesion material.
• Subjects who are pregnant.
• Subject with excessive hair at the application sites, scar tissue, tattoo, or coloration that would interfere with placement of test product or skin assessment.
• Subjects with diabetes, rheumatoid arthritis, poor circulation or have any clinically significant chronic illness.
• 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 test products or interfere with the skin assessments associated with the test products.
• Have history of significant dermatologic cancers (eg, melanoma, squamous cell carcinoma).
• Subjects who have used topical dermatological products in the application area within 24 hours prior to the test product application.
• Subject using a concomitant medication that, in the investigator's opinion, could interfere with the interpretation of study results. Examples of such drugs include non-steroidal anti-inflammatory drugs (NSAIDs, e.g., aspirin), topical or systemic corticosteroids, and cold/cough products containing antihistamines and/or either phentolamine, pseudoephedrine or phenylpropanolamine.
• Subjects who have received an investigational medication or device within 30 days prior to enrolment into this study.
• Subjects who are currently participating in an investigational study.
• Subject who are known to be noncompliant or are unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Temperature; Evaluate the temperature profile of the air activated 3-cell patch during 8 hours of wear	Device: Investigational Air-Activated Adhesive-Backed Heat Patch (3-Cell); Other: Temperature Probe
EXPERIMENTAL: Adhesion; Evaluate the adhesion with and without the presence of a temperature probe	Device: Investigational Air-Activated Adhesive-Backed Heat Patch (3-Cell)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patch Temperature	The temperature of the patch will be monitored by the use of a probe placed under the patch and recorded for the duration of the study.	8 hours
Patch Adhesion	Patch adhesion will be recorded for the duration of the study.	8 hours

Collaborators and Investigators

• Sponsor: Chattem, Inc.
• Investigators: Principal Investigator: Ellen Bonagua, MD, Chattem, Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (ACTUAL): September 1, 2014
• Study Completion (ACTUAL): October 1, 2014

Study Registration Dates

• First Submitted: September 11, 2014
• First Submitted That Met QC Criteria: September 15, 2014
• First Posted (ESTIMATE): September 16, 2014

Study Record Updates

• Last Update Posted (ACTUAL): March 17, 2017
• Last Update Submitted That Met QC Criteria: March 15, 2017
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: adhesion; temperature profile; air activated 3-cell patch
• Other Study ID Numbers: 2014011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO