Heat Wrap Device Safety With Age and Body Fat

Pfizer45 enrolled

Overview

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.

Safety measurements

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Back Pain

Interventions

thermal therapyDEVICE

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

ThermaCare heatwrapDEVICE

heatwrap, topical, one time application, 8 hour duration

Eligibility

Sex: ALLMin age: 18 YearsMax age: 84 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Loma Linda University

Loma Linda, California, United States

Outcomes

Primary Outcomes

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

Percentage of subjects with any adverse event

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

Data from ClinicalTrials.gov

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