HealthyNCT02241057
Investigational Air-Activated Adhesive-Backed Heat Patch (3-Cell)
A study testing Investigational Air-Activated Adhesive-Backed Heat Patch (3-Cell) and Temperature Probe in people with Healthy, run by Chattem, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Investigational Air-Activated Adhesive-Backed Heat Patch (3-Cell) and Temperature Probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy
- Being tested
- Investigational Air-Activated Adhesive-Backed Heat Patch (3-Cell), Temperature Probe
- Keywords
- temperature profile, air activated 3-cell patch, adhesion
- Medical subject headings
- Tissue Adhesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Air-Activated Adhesive-Backed Heat Patch (3-Cell)Device
Temperature ProbeOther
| Study group | Role | What they receive |
|---|---|---|
| Temperature | Experimental | Evaluate the temperature profile of the air activated 3-cell patch during 8 hours of wear Receives: Device: Investigational Air-Activated Adhesive-Backed Heat Patch (3-Cell); Other: Temperature Probe |
| Adhesion | Experimental | Evaluate the adhesion with and without the presence of a temperature probe Receives: Device: Investigational Air-Activated Adhesive-Backed Heat Patch (3-Cell) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patch Temperature
The temperature of the patch will be monitored by the use of a probe placed under the patch and recorded for the duration of the study.
Measured: 8 hours
Patch Adhesion
Patch adhesion will be recorded for the duration of the study.
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chattem, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ellen Bonagua, MD, Principal investigator, Chattem, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241057
- Sponsor's protocol ID
- 2014011
- Status last verified
- Jan 2016
- First submitted
- 11 Sep 2014
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label Study to Evaluate the Temperature Profile and Adhesion of an Air-Activated Adhesive-Backed Heat Patch in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02241057
- Acronym / sponsor ID
- 2014011
- Conditions
- Healthy
- Keywords
- temperature profile, air activated 3-cell patch, adhesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chattem, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 16 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Temperature | Experimental | Device: Investigational Air-Activated Adhesive-Backed Heat Patch (3-Cell), Other: Temperature ProbeEvaluate the temperature profile of the air activated 3-cell patch during 8 hours of wear |
| Adhesion | Experimental | Device: Investigational Air-Activated Adhesive-Backed Heat Patch (3-Cell)Evaluate the adhesion with and without the presence of a temperature probe |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational Air-Activated Adhesive-Backed Heat Patch (3-Cell) | Device | Adhesion, Temperature |
| Temperature Probe | Other | Temperature |
Primary outcome
Patch Temperature
Time frame: 8 hours
The temperature of the patch will be monitored by the use of a probe placed under the patch and recorded for the duration of the study.
Patch Adhesion
Time frame: 8 hours
Patch adhesion will be recorded for the duration of the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen Bonagua, MD principal investigator
Chattem, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Air-Activated Adhesive-Backed Heat Patch (3-Cell) and Temperature Probe in people with Healthy, run by Chattem, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patch Temperature (time frame: 8 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2017.