HealthyPhase 3NCT01055262
Safety, Tolerability And On-Body Temperature Of A Disposable Heatwrap Device For The Lower Back
A Phase 3 study testing Heatwrap 1 in people with Healthy, run by Pfizer.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Heatwrap 1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Feb 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
Read the detailed description
Purpose-To obtain safety , tolerability and on-body temperature of a heatwrap device for the lower back.
- Conditions
- Healthy
- Being tested
- Heatwrap 1
- Keywords
- Safety, tolerability, heatwrap, lower back, healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heatwrap 1Device
8 hours continuous topically-applied heat
| Study group | Role | What they receive |
|---|---|---|
| Heatwrap 1 | Experimental | Experimental heatwrap device for the lower back Receives: Device: Heatwrap 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a Significant Skin Event (Day 5 Cumulative)
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?"
Measured: Day 2 to Day 6
Secondary outcomes (7)
Percentage of Participants With Significant Skin Event (Days 1 Through 4 Cumulative)
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?"
Measured: Day 2 to Day 5
Time to First Significant Skin Event
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?"
Measured: Baseline to Day 6
Percentage of Participants With Any Non-zero Erythema Score or Elevated Response (Days 1 Through 5 Cumulative)
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.
Measured: Day 2 to Day 6
Time to First Report of Non-zero Erythema Score or Elevated Response
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.
Measured: Baseline to Day 6
Time to Worsening of Non-zero Erythema Score or Elevated Response Leading to Study Discontinuation
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?"
Measured: Baseline to Day 6
Percentage of Participants Discontinued From Wrap Wear by 8 Hours on Any Day
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.
Measured: Baseline to Day 6
Percentage of Participants Discontinued From Wrap Wear by 4 Hours on Any Day
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.
Measured: Baseline to Day 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055262
- Sponsor's protocol ID
- TC-09-06
- Other IDs
- TC-09-06
- Status last verified
- May 2012
- First submitted
- 21 Jan 2010
- Last updated
- 19 Jun 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study To Evaluate The Safety, Tolerability And On-Body Temperature Of A Disposable Heatwrap Device For The Lower Back
- ClinicalTrials.gov ID
- NCT01055262
- Acronym / sponsor ID
- TC-09-06
- Conditions
- Healthy
- Keywords
- Safety, tolerability, heatwrap, lower back, healthy subjects
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 25 Jan 2010 (estimated)
- Results
- Posted 19 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose-To obtain safety , tolerability and on-body temperature of a heatwrap device for the lower back.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heatwrap 1 | Experimental | Device: Heatwrap 1Experimental heatwrap device for the lower back |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heatwrap 18 hours continuous topically-applied heat | Device | Heatwrap 1 |
Primary outcome
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?"
7 secondary outcomes
Percentage of Participants With Significant Skin Event (Days 1 Through 4 Cumulative)
Time frame: Day 2 to Day 5
Time to First Significant Skin Event
Time frame: 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
Time to First Report of Non-zero Erythema Score or Elevated Response
Time frame: 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
Percentage of Participants Discontinued From Wrap Wear by 8 Hours on Any Day
Time frame: Baseline to Day 6
Percentage of Participants Discontinued From Wrap Wear by 4 Hours on Any Day
Time frame: Baseline to Day 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Heatwrap 1 in people with Healthy, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With a Significant Skin Event (Day 5 Cumulative) (time frame: Day 2 to Day 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2012.