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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
NameTimeMethod
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
NameTimeMethod
Percentage of subjects with any adverse eventduring 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

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