Heat Wrap Device Safety With Age and Body Fat
AN OPEN LABEL STUDY TO COMPARE THE EFFECTS OF AGE AND BODY FAT ON THE SAFETY OF TWO HEAT WRAP DEVICES IN HEALTHY SUBJECTS
2 other identifiers
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2011
CompletedStudy Start
First participant enrolled
May 5, 2011
CompletedFirst Posted
Study publicly available on registry
May 18, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 28, 2011
CompletedJuly 2, 2025
June 1, 2025
3 months
April 28, 2011
June 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Percentage of subjects with any adverse event
during and after wear for 28 days after last wear
Study Arms (2)
Treatment A
EXPERIMENTALthermal therapy
Treatment B
ACTIVE COMPARATORThermaCare Lower Back/Hip heatwrap
Interventions
heat therapy device, topical, two applications, at 0-3 hours and 4-6 hours on treatment day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (1)
Loma Linda University
Loma Linda, California, 92350, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2011
First Posted
May 18, 2011
Study Start
May 5, 2011
Primary Completion
July 28, 2011
Study Completion
July 28, 2011
Last Updated
July 2, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share