Investigational Air-Activated Adhesive-Backed Heat Patch (3-Cell)
| Status: | Terminated |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 4/21/2016 |
| Start Date: | September 2014 |
| End Date: | October 2014 |
A Randomized, Open-Label Study to Evaluate the Temperature Profile and Adhesion of an Air-Activated Adhesive-Backed Heat Patch in Healthy Volunteers
This is an open-label study. A total of approximately 60 subjects will be randomly assigned
to receive either the heat patch (30 subjects) with a temperature probe/skin reference probe
or a heat patch (30 subjects) alone. The study will consist of 2 visits.
to receive either the heat patch (30 subjects) with a temperature probe/skin reference probe
or a heat patch (30 subjects) alone. The study will consist of 2 visits.
Inclusion Criteria:
- Subjects who complete an appropriately administered informed consent process that
includes signing the consent form.
- Subjects 18-75 years old of either sex.
- Are of any skin type or race, providing the skin pigmentation will allow discernment
of erythema;
- Subjects who are in good general health.
- Subjects who are willing and able to have the test products applied as directed, and
comply with study instructions.
- Participants must be willing to restrict their activity for the 8 hour patch wear
time.
- All participants agree to wear a t-shirt provided by the site for the entire 8 hour
patch wear time.
Exclusion Criteria:
- Subjects who have a history of sensitivity to any of the test products or adhesion
material.
- Subjects who are pregnant.
- Subject with excessive hair at the application sites, scar tissue, tattoo, or
coloration that would interfere with placement of test product or skin assessment.
- Subjects with diabetes, rheumatoid arthritis, poor circulation or have any clinically
significant chronic illness.
- Subjects with active dermatitis (including sunburn) in the treatment area, or other
visible dermatological disease which, in the investigator's opinion, might interfere
with the response to the test products or interfere with the skin assessments
associated with the test products.
- Have history of significant dermatologic cancers (eg, melanoma, squamous cell
carcinoma).
- Subjects who have used topical dermatological products in the application area within
24 hours prior to the test product application.
- Subject using a concomitant medication that, in the investigator's opinion, could
interfere with the interpretation of study results. Examples of such drugs include
non-steroidal anti-inflammatory drugs (NSAIDs, e.g., aspirin), topical or systemic
corticosteroids, and cold/cough products containing antihistamines and/or either
phentolamine, pseudoephedrine or phenylpropanolamine.
- Subjects who have received an investigational medication or device within 30 days
prior to enrolment into this study.
- Subjects who are currently participating in an investigational study.
- Subject who are known to be noncompliant or are unlikely to comply with the
requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental
incapacity) in the opinion of the investigator.
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