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

Last updated on December 17, 2017

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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.
Show details

- 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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Safety, Tolerability And On-Body Temperature Of A Disposable Heatwrap Device For The Lower Back
An Open Label Study To Evaluate The Safety, Tolerability And On-Body Temperature Of A Disposable Heatwrap Device For The Lower Back
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.
Purpose-To obtain safety , tolerability and on-body temperature of a heatwrap device for the lower back.
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Healthy
Device: Heatwrap 1
8 hours continuous topically-applied heat
Experimental: Heatwrap 1
Experimental heatwrap device for the lower back
Intervention: Device: Heatwrap 1
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
169
February 2010
February 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 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.
Sexes Eligible for Study: All
35 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01055262
TC-09-06
TC-09-06
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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