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

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ClinicalTrials.gov Identifier: NCT01055262
Recruitment Status : Completed
First Posted : January 25, 2010
Results First Posted : June 19, 2012
Last Update Posted : June 19, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Device: Heatwrap 1 Phase 3

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 169 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2010
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010
Arms and Interventions
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Arm Intervention/treatment
Experimental: Heatwrap 1
Experimental heatwrap device for the lower back
 Device: Heatwrap 1
8 hours continuous topically-applied heat


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01055262


Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01055262     History of Changes
Other Study ID Numbers: TC-09-06
TC-09-06
First Posted: January 25, 2010    Key Record Dates
Results First Posted: June 19, 2012
Last Update Posted: June 19, 2012
Last Verified: May 2012

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