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

• Percentage of Participants With Significant Skin Event (Days 1 Through 4 Cumulative) [ Time Frame: Day 2 to Day 5 ] [ Designated as safety issue: Yes ]
  Events associated with Day X wear (eg, Day 4) assessed on the morning of Day X+1 (eg, Day 5). Significant skin event: at least moderate erythema, elevated response or pain upon touch (associated with non-zero erythema). Erythema grading scale: 0 (no visible erythema) to 3.0 (severe erythema, very intense redness) with 0.5 point increments. Moderate erythema (2.0): definite redness. Elevated responses: edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda or follicular response. Pain upon touch: skin grader asked "Does your skin hurt when I touch it?"
• Time to First Significant Skin Event [ Time Frame: Baseline to Day 6 ] [ Designated as safety issue: Yes ]
  Significant skin event: at least moderate erythema, elevated response or pain upon touch (associated with non-zero erythema). Erythema grading scale: 0 (no visible erythema) to 3.0 (severe erythema, very intense redness) with 0.5 point increments. Moderate erythema (2.0): definite redness. Elevated responses: edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda or follicular response. Pain upon touch: skin grader asked "Does your skin hurt when I touch it?"
• Percentage of Participants With Any Non-zero Erythema Score or Elevated Response (Days 1 Through 5 Cumulative) [ Time Frame: Day 2 to Day 6 ] [ Designated as safety issue: Yes ]
  Events associated with Day X wear (eg, Day 5) assessed on the morning of Day X+1 (eg, Day 6). Erythema grading scale was a 7 point scale that ranged from 0 (no visible erythema) to 3.0 (severe erythema, very intense redness), with 0.5 point increments. Elevated responses included edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda, or follicular response.
• Time to First Report of Non-zero Erythema Score or Elevated Response [ Time Frame: Baseline to Day 6 ] [ Designated as safety issue: Yes ]
  Erythema grading scale was a 7 point scale that ranged from 0 (no visible erythema) to 3.0 (severe erythema, very intense redness), with 0.5 point increments. Elevated responses included edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda, or follicular response.
• Time to Worsening of Non-zero Erythema Score or Elevated Response Leading to Study Discontinuation [ Time Frame: Baseline to Day 6 ] [ Designated as safety issue: Yes ]
  Participants discontinued study due to adverse event (AE) if erythema ≥ 2.0, pain upon touch associated with non-zero erythema score or elevated response on the morning of Day X+1. Erythema grading scale: 0 (no visible erythema) to 3.0 (severe erythema, very intense redness) with 0.5 point increments. Elevated responses included edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda or follicular response. Pain upon touch: skin grader asked "Does your skin hurt when I touch it?"
• Percentage of Participants Discontinued From Wrap Wear by 8 Hours on Any Day [ Time Frame: Baseline to Day 6 ] [ Designated as safety issue: Yes ]
  Skin assessments performed prior to heatwrap application; participant discontinued wrap wear for day (8 hours) if erythema score ≥ 2 with pain upon touch or elevated response. Outcome included those who discontinued wrap wear by 4 hours on same day. Erythema grading scale: 7 point scale that ranged from 0 (no visible erythema) to 3.0 (severe erythema, very intense redness) with 0.5 point increments. Moderate erythema (2.0) was definite redness. Elevated responses included edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda or follicular response.
• Percentage of Participants Discontinued From Wrap Wear by 4 Hours on Any Day [ Time Frame: Baseline to Day 6 ] [ Designated as safety issue: Yes ]
  Skin assessments performed after 4 hours of wear, participants discontinued wrap wear for remainder of day (4 hours) if erythema score ≥ 2 with pain upon touch or elevated response. Erythema grading scale: 7 point scale ranging from 0 (no visible erythema) to 3.0 (severe erythema, very intense redness) with 0.5 point increments. Moderate erythema (2.0) was definite redness. Elevated responses included edema, papules, vesicle (≤ 0.5 cm diameter), bullae (> 0.5 cm diameter), miliaria rubra, profunda and follicular response.

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.