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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Heatwrap 1; Experimental heatwrap device for the lower back	Device: Heatwrap 1; 8 hours continuous topically-applied heat

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	35 Years and older (Adult, Senior)
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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

Pfizer

Investigators

Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

To obtain contact information for a study center near you, click here. 

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01055262 History of Changes
Other Study ID Numbers:	TC-09-06
First Posted:	January 25, 2010
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