Back Pain
Conditions
Keywords
heat, device, safety, performance, heatwrap, elderly, overweight
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
Interventions
DEVICEthermal therapy
heat therapy device, topical, two applications, at 0-3 hours and 4-6 hours on treatment day
DEVICEThermaCare heatwrap
heatwrap, topical, one time application, 8 hour duration
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| 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) | morning after product wear through 15 days after last product application |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of subjects with any adverse event | during and after wear for 28 days after last wear |
Countries
United States
Outcome results
None listed