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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01055262
First received: January 21, 2010
Last updated: May 7, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Healthy
Device: Heatwrap 1
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: An Open Label Study To Evaluate The Safety, Tolerability And On-Body Temperature Of A Disposable Heatwrap Device For The Lower Back

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Percentage of Participants With a Significant Skin Event (Day 5 Cumulative) [ Time Frame: Day 2 to Day 6 ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • 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.


Enrollment: 169
Study Start Date: January 2010
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Heatwrap 1
Experimental heatwrap device for the lower back
Device: Heatwrap 1
8 hours continuous topically-applied heat

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01055262

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01055262     History of Changes
Other Study ID Numbers: TC-09-06, TC-09-06
Study First Received: January 21, 2010
Results First Received: May 7, 2012
Last Updated: May 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Safety
tolerability
heatwrap
lower back
healthy subjects

ClinicalTrials.gov processed this record on July 23, 2014