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OpenTrials
Completed

NCT Number: NCT01355653

Heat Wrap Device Safety With Age and Body Fat

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.

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Key information

Conditions

Back Pain Body Weight Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University

Loma Linda, California, 92350, United States

About this study

Safety measurements

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

thermal therapy

Device

heat therapy device, topical, two applications, at 0-3 hours and 4-6 hours on treatment day

ThermaCare heatwrap

Device

heatwrap, topical, one time application, 8 hour duration

Primary outcomes

  1. 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

Secondary outcomes

  1. Percentage of subjects with any adverse event

    Time frame: during and after wear for 28 days after last wear

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 18, 2011
Registry last updated
Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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