Heat Wrap Device Safety With Age and Body Fat

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01355653
First received: April 28, 2011
Last updated: August 26, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Back Pain
Device: thermal therapy
Device: marketed heatwrap

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: An Open Label Study To Compare The Effects Of Age And Body Fat On The Safety Of Two Heat Wrap Devices In Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage of subjects with any adverse event [ Time Frame: during and after wear for 28 days after last wear ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 57
Study Start Date: April 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment A
thermal therapy
Device: thermal therapy
heat therapy device, topical, two applications, at 0-3 hours and 4-6 hours on treatment day
Active Comparator: Treatment B
ThermaCare Lower Back/Hip heatwrap
Device: marketed heatwrap
heatwrap, topical, one time application, 8 hour duration

Detailed Description:

Safety measurements

  Eligibility

Ages Eligible for Study:   18 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 sensitivity or allergy to device components in contact with skin
  • Diabetes
  • Any active skin disease or tattoos at the test site that would affect participation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01355653

Locations
United States, California
Pfizer Investigational Site
Loma Linda, California, United States, 92350
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01355653     History of Changes
Other Study ID Numbers: B3571002, TC-09-12
Study First Received: April 28, 2011
Last Updated: August 26, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
heat
device
safety
performance
heatwrap
elderly
overweight

Additional relevant MeSH terms:
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014