Trial Outcomes & Findings for Safety, Tolerability And On-Body Temperature Of A Disposable Heatwrap Device For The Lower Back (NCT NCT01055262)

Results Overview

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?"

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

169 participants

Primary outcome timeframe

Day 2 to Day 6

Results posted on

2012-06-19

Participant Flow

Participant milestones

Participant milestones
Measure	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).
Overall Study STARTED	169
Overall Study COMPLETED	160
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Reasons for withdrawal
Measure	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).
Overall Study Adverse Event	5
Overall Study Protocol Violation	3
Overall Study Uncooperativeness	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ThermaCare Overnight HeatWrap n=169 Participants 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).
Age Continuous	55.9 years n=93 Participants
Sex: Female, Male Female	115 Participants n=93 Participants
Sex: Female, Male Male	54 Participants n=93 Participants

PRIMARY outcome

Timeframe: Day 2 to Day 6

Population: Safety population: participants who wore the product at least once during the study

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?"

Outcome measures

Outcome measures
Measure	ThermaCare Overnight HeatWrap n=169 Participants 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).
Percentage of Participants With a Significant Skin Event (Day 5 Cumulative)	2.4 Percentage of participants Interval 0.1 to 4.7

SECONDARY outcome

Timeframe: Day 2 to Day 5

Population: Safety population

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?"

Outcome measures

Outcome measures
Measure	ThermaCare Overnight HeatWrap n=169 Participants 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).
Percentage of Participants With Significant Skin Event (Days 1 Through 4 Cumulative) Day 2	1.2 Percentage of participants Interval 0.0 to 2.8
Percentage of Participants With Significant Skin Event (Days 1 Through 4 Cumulative) Day 3	2.4 Percentage of participants Interval 0.1 to 4.7
Percentage of Participants With Significant Skin Event (Days 1 Through 4 Cumulative) Day 4	2.4 Percentage of participants Interval 0.1 to 4.7
Percentage of Participants With Significant Skin Event (Days 1 Through 4 Cumulative) Day 1	1.2 Percentage of participants Interval 0.0 to 2.8

SECONDARY outcome

Timeframe: Baseline to Day 6

Population: Safety population; Number of participants analyzed (N) = number of participants with 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?"

Outcome measures

Outcome measures
Measure	ThermaCare Overnight HeatWrap n=4 Participants 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).
Time to First Significant Skin Event	2.0 Days Standard Deviation 1.2

SECONDARY outcome

Timeframe: Day 2 to Day 6

Population: Safety Population

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.

Outcome measures

Outcome measures
Measure	ThermaCare Overnight HeatWrap n=169 Participants 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).
Percentage of Participants With Any Non-zero Erythema Score or Elevated Response (Days 1 Through 5 Cumulative) Day 3	5.3 Percentage of participants Interval 1.9 to 8.7
Percentage of Participants With Any Non-zero Erythema Score or Elevated Response (Days 1 Through 5 Cumulative) Day 4	6.5 Percentage of participants Interval 2.8 to 10.2
Percentage of Participants With Any Non-zero Erythema Score or Elevated Response (Days 1 Through 5 Cumulative) Day 5	6.5 Percentage of participants Interval 2.8 to 10.2
Percentage of Participants With Any Non-zero Erythema Score or Elevated Response (Days 1 Through 5 Cumulative) Day 1	3.0 Percentage of participants Interval 0.4 to 5.5
Percentage of Participants With Any Non-zero Erythema Score or Elevated Response (Days 1 Through 5 Cumulative) Day 2	3.6 Percentage of participants Interval 0.8 to 6.3

SECONDARY outcome

Timeframe: Baseline to Day 6

Population: Safety population; N = participants with any application site finding

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.

Outcome measures

Outcome measures
Measure	ThermaCare Overnight HeatWrap n=11 Participants 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).
Time to First Report of Non-zero Erythema Score or Elevated Response	2.2 Days Standard Deviation 1.3

SECONDARY outcome

Timeframe: Baseline to Day 6

Population: Safety population; N = participants with a 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?"

Outcome measures

Outcome measures
Measure	ThermaCare Overnight HeatWrap n=4 Participants 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).
Time to Worsening of Non-zero Erythema Score or Elevated Response Leading to Study Discontinuation	NA Days Standard Deviation NA Not available (NA): No participant experienced a worsening of a nonzero erythema score or elevated response leading to study discontinuation.

SECONDARY outcome

Timeframe: Baseline to Day 6

Population: Safety Population

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.

Outcome measures

Outcome measures
Measure	ThermaCare Overnight HeatWrap n=169 Participants 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).
Percentage of Participants Discontinued From Wrap Wear by 8 Hours on Any Day	0.6 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to Day 6

Population: Safety Population

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.

Outcome measures

Outcome measures
Measure	ThermaCare Overnight HeatWrap n=169 Participants 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).
Percentage of Participants Discontinued From Wrap Wear by 4 Hours on Any Day	0.6 Percentage of participants

Adverse Events

ThermaCare Overnight HeatWrap

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	ThermaCare Overnight HeatWrap n=169 participants at risk 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).
General disorders Application site scab	3.0% 5/169
General disorders Application site vesicles	1.8% 3/169
General disorders Application site erosion	0.59% 1/169
General disorders Application site exfoliation	0.59% 1/169
General disorders Aplication site oedema	0.59% 1/169
General disorders Application site pruritus	0.59% 1/169
General disorders Application site scar	0.59% 1/169
General disorders Skin hyperpigmentation	0.59% 1/169
General disorders Erythema	2.4% 4/169

Additional Information

Pfizer Clinical Trials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER