Safety, Tolerability And On-Body Temperature Of A Disposable Heatwrap Device For The Lower Back
NCT01055262
ABOUT THIS STUDY
FOR MORE INFORMATION
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- The subject is a male or female in generally good health greater or equal to 35 years of age;
- Female subjects of child-bearing potential and those who are post-menopausal for less than 2 years must be using a medically-approved method of contraception (i.e., oral, transdermal, or implanted contraceptive hormones, cervical cap, intrauterine device, diaphragm, condom, abstinence, or surgical sterility including partner's vasectomy);
- The subject has a waist-hip circumference of between 27-47 inches inclusive.
- The subject is a pregnant or lactating woman;
- The subject is diabetic;
- The subject has a history of melanoma, squamous or basal cell carcinoma in the area of
application of the lower back and hip;
- The subject has any active skin disease which may contraindicate participation,
including eczema, rash, broken or irritated skin, contact dermatitis and atopic
dermatitis, or any skin condition that may be aggravated by heat;
- The subject has used (within the previous week) or is using any topical drug or
heatwrap or electrical heat pads at the application site; or
- The subject has damaged skin in, or around the test sites which includes sunburn,
uneven skin tones, tattoos, scars or other disfiguration at the application site,
including an erythema grading of greater than 0 at the application site.
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Descriptive Information | ||||
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Brief Title ICMJE | Safety, Tolerability And On-Body Temperature Of A Disposable Heatwrap Device For The Lower Back | |||
Official Title ICMJE | An Open Label Study To Evaluate The Safety, Tolerability And On-Body Temperature Of A Disposable Heatwrap Device For The Lower Back | |||
Brief Summary | The objectives of this study are to evaluate the dermal safety and on-body temperature of a disposable heatwrap product when worn while in a supine position for five consecutive days. The product will be worn on the back for approximately 8 hours per 24 hour period. | |||
Detailed Description | Purpose-To obtain safety , tolerability and on-body temperature of a heatwrap device for the lower back. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) | |||
Condition ICMJE | Healthy | |||
Intervention ICMJE | Device: Heatwrap 1
8 hours continuous topically-applied heat | |||
Study Arms ICMJE | Experimental: Heatwrap 1
Experimental heatwrap device for the lower back Intervention: Device: Heatwrap 1 | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 169 | |||
Original Estimated Enrollment ICMJE | 165 | |||
Actual Study Completion Date ICMJE | February 2010 | |||
Actual Primary Completion Date | February 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 35 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | United States | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01055262 | |||
Other Study ID Numbers ICMJE | TC-09-06 TC-09-06 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | May 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |