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.

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.