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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

169 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-02-28

Brief Summary

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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.

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Detailed Description

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Purpose-To obtain safety , tolerability and on-body temperature of a heatwrap device for the lower back.

Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Heatwrap 1

Experimental heatwrap device for the lower back

Group Type EXPERIMENTAL

Heatwrap 1

Intervention Type DEVICE

8 hours continuous topically-applied heat

Interventions

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Heatwrap 1

8 hours continuous topically-applied heat

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes