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Safety, Tolerability And On-Body Temperature Of A Disposable Heatwrap Device For The Lower Back

Last updated on March 15, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
35 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT01055262
Pfizer
Completed
Safety, Tolerability And On-Body Temperature Of A Disposable Heatwrap Device For The Lower Back

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