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

Pfizer1 site in 1 country45 target enrollmentMay 5, 2011

ConditionsBack Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Back Pain
Sponsor: Pfizer
Enrollment: 45
Locations: 1
Primary Endpoint: 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)
Status: Completed
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

Safety measurements

Registry

clinicaltrials.gov

Start Date

May 5, 2011

End Date

July 28, 2011

Last Updated

10 months ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Pfizer

Responsible Party

Sponsor

Eligibility Criteria

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
•Any active skin disease or tattoos at the test site that would affect participation

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