Heat Wrap Device Safety With Age and Body Fat
Not Applicable
Completed
- Conditions
- Back Pain
- Registration Number
- NCT01355653
- Lead Sponsor
- Pfizer
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Percentage of subjects with any adverse event during and after wear for 28 days after last wear
Trial Locations
- Locations (1)
Loma Linda University
🇺🇸Loma Linda, California, United States
Loma Linda University🇺🇸Loma Linda, California, United States