- 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.