Healthy
Conditions
Keywords
Safety, tolerability, heatwrap, lower back, healthy subjects
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.
Detailed description
Purpose-To obtain safety , tolerability and on-body temperature of a heatwrap device for the lower back.
Interventions
DEVICEHeatwrap 1
8 hours continuous topically-applied heat
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Significant Skin Event (Day 5 Cumulative) | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to First Significant Skin Event | 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? |
| Percentage of Participants With Any Non-zero Erythema Score or Elevated Response (Days 1 Through 5 Cumulative) | 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. |
| Time to First Report of Non-zero Erythema Score or Elevated Response | 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. |
| Percentage of Participants With Significant Skin Event (Days 1 Through 4 Cumulative) | 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? |
| Percentage of Participants Discontinued From Wrap Wear by 8 Hours on Any Day | 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. |
| Percentage of Participants Discontinued From Wrap Wear by 4 Hours on Any Day | 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. |
| Time to Worsening of Non-zero Erythema Score or Elevated Response Leading to Study Discontinuation | 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? |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ThermaCare Overnight HeatWrap Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position). | 169 |
| Total | 169 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 5 |
| Overall Study | Protocol Violation | 3 |
| Overall Study | Uncooperativeness | 1 |
Baseline characteristics
| Characteristic | ThermaCare Overnight HeatWrap |
|---|---|
| Age Continuous | 55.9 years |
| Sex: Female, Male Female | 115 Participants |
| Sex: Female, Male Male | 54 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 169 |
| serious Total, serious adverse events | 0 / 169 |
Outcome results
Primary
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?
Time frame: Day 2 to Day 6
Population: Safety population: participants who wore the product at least once during the study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ThermaCare Overnight HeatWrap | Percentage of Participants With a Significant Skin Event (Day 5 Cumulative) | 2.4 Percentage of participants |
Secondary
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.
Time frame: Baseline to Day 6
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ThermaCare Overnight HeatWrap | Percentage of Participants Discontinued From Wrap Wear by 4 Hours on Any Day | 0.6 Percentage of participants |
Secondary
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.
Time frame: Baseline to Day 6
Population: Safety Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ThermaCare Overnight HeatWrap | Percentage of Participants Discontinued From Wrap Wear by 8 Hours on Any Day | 0.6 Percentage of participants |
Secondary
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.
Time frame: Day 2 to Day 6
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ThermaCare Overnight HeatWrap | Percentage of Participants With Any Non-zero Erythema Score or Elevated Response (Days 1 Through 5 Cumulative) | Day 1 | 3.0 Percentage of participants |
| ThermaCare Overnight HeatWrap | Percentage of Participants With Any Non-zero Erythema Score or Elevated Response (Days 1 Through 5 Cumulative) | Day 2 | 3.6 Percentage of participants |
| ThermaCare Overnight HeatWrap | Percentage of Participants With Any Non-zero Erythema Score or Elevated Response (Days 1 Through 5 Cumulative) | Day 3 | 5.3 Percentage of participants |
| ThermaCare Overnight HeatWrap | Percentage of Participants With Any Non-zero Erythema Score or Elevated Response (Days 1 Through 5 Cumulative) | Day 4 | 6.5 Percentage of participants |
| ThermaCare Overnight HeatWrap | Percentage of Participants With Any Non-zero Erythema Score or Elevated Response (Days 1 Through 5 Cumulative) | Day 5 | 6.5 Percentage of participants |
Secondary
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?
Time frame: Day 2 to Day 5
Population: Safety population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ThermaCare Overnight HeatWrap | Percentage of Participants With Significant Skin Event (Days 1 Through 4 Cumulative) | Day 1 | 1.2 Percentage of participants |
| ThermaCare Overnight HeatWrap | Percentage of Participants With Significant Skin Event (Days 1 Through 4 Cumulative) | Day 2 | 1.2 Percentage of participants |
| ThermaCare Overnight HeatWrap | Percentage of Participants With Significant Skin Event (Days 1 Through 4 Cumulative) | Day 3 | 2.4 Percentage of participants |
| ThermaCare Overnight HeatWrap | Percentage of Participants With Significant Skin Event (Days 1 Through 4 Cumulative) | Day 4 | 2.4 Percentage of participants |
Secondary
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.
Time frame: Baseline to Day 6
Population: Safety population; N = participants with any application site finding
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ThermaCare Overnight HeatWrap | Time to First Report of Non-zero Erythema Score or Elevated Response | 2.2 Days | Standard Deviation 1.3 |
Secondary
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?
Time frame: Baseline to Day 6
Population: Safety population; Number of participants analyzed (N) = number of participants with significant skin event.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ThermaCare Overnight HeatWrap | Time to First Significant Skin Event | 2.0 Days | Standard Deviation 1.2 |
Secondary
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?
Time frame: Baseline to Day 6
Population: Safety population; N = participants with a non-zero erythema score or elevated response leading to study discontinuation.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ThermaCare Overnight HeatWrap | Time to Worsening of Non-zero Erythema Score or Elevated Response Leading to Study Discontinuation | NA Days |