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Completed

NCT Number: NCT01055262

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.

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Key information

Conditions

Healthy

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Heatwrap 1

Device

8 hours continuous topically-applied heat

Primary outcomes

  1. Percentage of Participants With a Significant Skin Event (Day 5 Cumulative)

    Time frame: Day 2 to Day 6

    Events associated with Day X wear (eg, Day 5) assessed morning of Day X+1 (eg, Day 6). 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 increments. Moderate erythema (2.0): definite redness. Elevated response: edema, papules, vesicle (≤ 0.5 centimeter [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?"

Secondary outcomes

  1. Percentage of Participants With Significant Skin Event (Days 1 Through 4 Cumulative)

    Time frame: Day 2 to Day 5

    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?"

  2. Time to First Significant Skin Event

    Time frame: Baseline to Day 6

    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?"

  3. Percentage of Participants With Any Non-zero Erythema Score or Elevated Response (Days 1 Through 5 Cumulative)

    Time frame: Day 2 to Day 6

    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.

  4. Time to First Report of Non-zero Erythema Score or Elevated Response

    Time frame: Baseline to 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.

  5. Time to Worsening of Non-zero Erythema Score or Elevated Response Leading to Study Discontinuation

    Time frame: Baseline to Day 6

    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?"

  6. Percentage of Participants Discontinued From Wrap Wear by 8 Hours on Any Day

    Time frame: Baseline to Day 6

    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.

  7. Percentage of Participants Discontinued From Wrap Wear by 4 Hours on Any Day

    Time frame: Baseline to Day 6

    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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

An Open Label Study To Evaluate The Safety, Tolerability And On-Body Temperature Of A Disposable Heatwrap Device For The Lower Back

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jan 25, 2010
Registry last updated
Jun 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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