Clinical trial NCT01055262: Safety, Tolerability And On-Body Temperature Of A Disposable Heatwrap Device For The Lower Back
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: Safety
tolerability
heatwrap
lower back
healthy subjects
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-01-25
Enrollment: 169
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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.

Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With a Significant Skin Event (Day 5 Cumulative)
timeFrame: Day 2 to Day 6
Secondary outcomes:
measure: Percentage of Participants With Significant Skin Event (Days 1 Through 4 Cumulative)
timeFrame: Day 2 to Day 5
measure: Time to First Significant Skin Event
timeFrame: Baseline to Day 6
measure: Percentage of Participants With Any Non-zero Erythema Score or Elevated Response (Days 1 Through 5 Cumulative)
timeFrame: Day 2 to Day 6
measure: Time to First Report of Non-zero Erythema Score or Elevated Response
timeFrame: Baseline to Day 6
measure: Time to Worsening of Non-zero Erythema Score or Elevated Response Leading to Study Discontinuation
timeFrame: Baseline to Day 6
measure: Percentage of Participants Discontinued From Wrap Wear by 8 Hours on Any Day
timeFrame: Baseline to Day 6
measure: Percentage of Participants Discontinued From Wrap Wear by 4 Hours on Any Day
timeFrame: Baseline to Day 6
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: