Heat Wrap Device Safety With Age and Body Fat

June 25, 2025 updated by: Pfizer

AN OPEN LABEL STUDY TO COMPARE THE EFFECTS OF AGE AND BODY FAT ON THE SAFETY OF TWO HEAT WRAP DEVICES IN HEALTHY SUBJECTS

This study is designed to compare the safety, as measured by skin findings and adverse events, of two different heat devices in elderly, overweight, and elderly and overweight subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Safety measurements

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • 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
    • California
      • Loma Linda, California, United States, 92350
        • Loma Linda University

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

Ages Eligible for Study

18 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Males or females in generally good health, and who are either 18-54 years of age with a body mass index of ≥ 30 kg/m2
  • or 55-84 years of age and with a body mass index ≥ 30 kg/m2 or < 30 kg/m2
  • Females who are not pregnant or breastfeeding
  • Subject is medically cleared for study participation

Exclusion Criteria:

  • No sensitivitiy or allergy to device components in contact with skin
  • Diabetes
  • Any active skin disease or tattoos at the test site that would affect participation

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: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment A
thermal therapy
Device: thermal therapy
heat therapy device, topical, two applications, at 0-3 hours and 4-6 hours on treatment day
Active Comparator: Treatment B
ThermaCare Lower Back/Hip heatwrap
Device: ThermaCare heatwrap
heatwrap, topical, one time application, 8 hour duration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects with any thermal-related skin events (defined as elevated skin response, erythema ≥ 2.0 [moderate], or pain upon touch plus non-zero erythema)
Time Frame: morning after product wear through 15 days after last product application
morning after product wear through 15 days after last product application

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects with any adverse event
Time Frame: during and after wear for 28 days after last wear
during and after wear for 28 days after last wear

Collaborators and Investigators

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

Sponsor

Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Actual)

May 5, 2011

Primary Completion (Actual)

July 28, 2011

Study Completion (Actual)

July 28, 2011

Study Registration Dates

First Submitted

April 28, 2011

First Submitted That Met QC Criteria

May 17, 2011

First Posted (Estimated)

May 18, 2011

Study Record Updates

Last Update Posted (Actual)

July 2, 2025

Last Update Submitted That Met QC Criteria

June 25, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B3571002
  • TC-09-12 (Other Identifier: Alias Study Number)

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.

Clinical Trials on Back Pain

Clinical Trials on thermal therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Switzerland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe