- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01055262
Safety, Tolerability And On-Body Temperature Of A Disposable Heatwrap Device For The Lower Back
May 7, 2012 updated by: Pfizer
An Open Label Study To Evaluate The 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.
Study Overview
Detailed Description
Purpose-To obtain safety , tolerability and on-body temperature of a heatwrap device for the lower back.
Study Type
Interventional
Enrollment (Actual)
169
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Heatwrap 1
Experimental heatwrap device for the lower back
|
8 hours continuous topically-applied heat
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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?"
|
Day 2 to Day 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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?"
|
Day 2 to Day 5
|
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?"
|
Baseline to Day 6
|
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.
|
Day 2 to Day 6
|
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.
|
Baseline to Day 6
|
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?"
|
Baseline to Day 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.
|
Baseline to Day 6
|
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.
|
Baseline to Day 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
January 21, 2010
First Submitted That Met QC Criteria
January 22, 2010
First Posted (Estimate)
January 25, 2010
Study Record Updates
Last Update Posted (Estimate)
June 19, 2012
Last Update Submitted That Met QC Criteria
May 7, 2012
Last Verified
May 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TC-09-06
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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