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

NCT01055262 | Completed Phase 3 Results

• 1 other identifier: TC-09-06
• Study Type: interventional
• Target: 169
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

Safety; tolerability; heatwrap; lower back; healthy subjects

Outcome Measures

Primary Outcomes (1)

• 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?"

  Day 2 to Day 6

Secondary Outcomes (7)

• Percentage of Participants With Significant Skin Event (Days 1 Through 4 Cumulative)

  Day 2 to Day 5

• Time to First Significant Skin Event

  Baseline to Day 6

• Percentage of Participants With Any Non-zero Erythema Score or Elevated Response (Days 1 Through 5 Cumulative)

  Day 2 to Day 6

• Time to First Report of Non-zero Erythema Score or Elevated Response

  Baseline to Day 6

• Time to Worsening of Non-zero Erythema Score or Elevated Response Leading to Study Discontinuation

  Baseline to Day 6

Study Arms (1)

Heatwrap 1

EXPERIMENTAL

Experimental heatwrap device for the lower back

Device: Heatwrap 1

Interventions

Heatwrap 1 DEVICE

8 hours continuous topically-applied heat

Heatwrap 1

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Related Links

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

Results Point of Contact

• Title: Pfizer Clinical Trials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquires@Pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2010
• First Posted: January 25, 2010
• Study Start: January 1, 2010
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: June 19, 2012
• Results First Posted: June 19, 2012

Record last verified: 2012-05