HealthyNCT02080143
A Comparative Study to Evaluate Two Air-Activated Adhesive Backed Heat Patches
A study testing Thermal Adhesion Patch in people with Healthy, run by Chattem, Inc. at 1 site in United States.
Trial summary
A disposable, air-activated, adhesive backed heat patch is being evaluated. Study terminated -O subjects. 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?
- Thermal Adhesion Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to May 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 IRB-approved consent form;
- subjects 18-75 years old of each sex;
- are of any skin type or race, providing the skin pigmentation will allow discernment of erythema;
- subjects who are in good general health and free of any disease state or physical condition;
- subjects who are willing and able to have the study products applied as directed, and comply with study instructions;
- subjects must be willing to restrict their activity for the 8 hour patch wear time so that patches and thermocouples do not come loose;
- subjects must be willing to wear a pouch containing the thermologger and thermocouple wiring for the entire 8 hours;
- subjects who are 55 years or older agree to wear a t-shirt provided by the site for the entire 8 hour patch wear time.
Who cannot join
- Subjects who are pregnant or nursing;
- subjects with excessive hair at the application site, scar tissue, tattoo or coloration that would interfere with the placement of the study product or the skin assessment;
- subjects with diabetes or poor circulation or have any clinically significant chronic illness which could place the subject at increased risk during participation or result in inappropriate dermal response during the study;
- subjects unable to feel pain or heat (e.g., subjects with neuropathy);
- 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 study products or interfere with the skin assessments associated with the study products;
- have history of significant dermatologic cancers or neoplasms in the treatment area;
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- subjects who have used topical dermatological products in the application area within 24 hours prior to anticipated study product application;
- subjects using a concomitant medication that, in the investigator's opinion, could interfere with the interpretation of the study results. Examples of such drugs include vasoactive (constrictor or dilator) medications, prescription or OTC, that could modulate blood flow, within 24 hours prior to or during the application of study products, including nitroglycerin, non-steroidal anti-inflammatory products (NSAIDs, e.g., ibuprofen, aspirin (<=81 mg/day is acceptable)), topical corticosteroids and OTC cough/cold products including antihistamines and/or either phenylpropanolamine or phentolamine;
- subjects who have used systemic steroids (i.e., oral, IV, IM or intra-articular) 30 days prior to the application of test articles (intranasal/inhaled steroids are acceptable);
- subjects who have received an investigational medication or device within 30 days prior to enrollment into this study;
- subjects who have a history of sensitivity to any of the study products or adhesion materials;
- subjects who are currently participating in an investigational study;
- subjects who are known to be noncompliant or are unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, product 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, Comparative Study To Evaluate the Adhesion and Temperature Properties of Two Air-Activated, Adhesive Backed Heat Patches in Healthy Volunteers
A disposable, air-activated, adhesive backed heat patch is being evaluated.
Study terminated -O subjects.
Read the detailed description
Study Protocol Terminated--0 subjects
- Conditions
- Healthy
- Being tested
- Thermal Adhesion Patch
- Keywords
- Skin temperature measurements, Heat patch adhesion, Dermal irritation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal Adhesion PatchDevice
Also called Experimental Adhesion Patch
Thermal Adhesion PatchDevice
Also called Marketed ThermaCare Thermal Adhesion Patch
| Study group | Role | What they receive |
|---|---|---|
| Air Activated Heat Patch | Experimental | The experimental air activated heat patch will be worn by the subjects for 8 hours. Receives: Device: Thermal Adhesion Patch |
| Marketed ThermaCare Air Activated Heat Patch | Active comparator | The marketed air activated heat patch will be worn by the subjects for 8 hours. Receives: Device: Thermal Adhesion Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heat Intensity
Assessed using sensors.
Measured: 8 hours
Secondary outcomes (2)
Adhesion Evaluation
Adhesion will be evaluated by visual assessment.
Measured: 8 hours
Irritation Evaluation
At the conclusion of the study and upon removal of the heat patch the application area will be observed by a trained skin grader for visual signs of irritation.
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 posted6 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2014
- Study completionMay 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chattem, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Albert Q. Tejada, MD, Principal investigator, Radiant Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02080143
- Sponsor's protocol ID
- 2014003
- Status last verified
- Aug 2020
- First submitted
- 4 Mar 2014
- Last updated
- 12 Aug 2020
- 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 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Comparative Study To Evaluate the Adhesion and Temperature Properties of Two Air-Activated, Adhesive Backed Heat Patches in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02080143
- Acronym / sponsor ID
- 2014003
- Conditions
- Healthy
- Keywords
- Skin temperature measurements, Heat patch adhesion, Dermal irritation
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Chattem, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 6 Mar 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.
A disposable, air-activated, adhesive backed heat patch is being evaluated.
Study terminated -O subjects.
Detailed description
Study Protocol Terminated--0 subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Air Activated Heat Patch | Experimental | Device: Thermal Adhesion PatchThe experimental air activated heat patch will be worn by the subjects for 8 hours. |
| Marketed ThermaCare Air Activated Heat Patch | Active comparator | Device: Thermal Adhesion PatchThe marketed air activated heat patch will be worn by the subjects for 8 hours. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects who complete an appropriately administered informed consent process that includes signing the IRB-approved consent form;
- subjects 18-75 years old of each sex;
- are of any skin type or race, providing the skin pigmentation will allow discernment of erythema;
- subjects who are in good general health and free of any disease state or physical condition;
- subjects who are willing and able to have the study products applied as directed, and comply with study instructions;
Key exclusion criteria (13 listed)
- Subjects who are pregnant or nursing;
- subjects with excessive hair at the application site, scar tissue, tattoo or coloration that would interfere with the placement of the study product or the skin assessment;
- subjects with diabetes or poor circulation or have any clinically significant chronic illness which could place the subject at increased risk during participation or result in inappropriate dermal response during the study;
- subjects unable to feel pain or heat (e.g., subjects with neuropathy);
- 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 study products or interfere with the skin assessments associated with the study 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 |
|---|---|---|
| Thermal Adhesion PatchAlso: Experimental Adhesion Patch | Device | Air Activated Heat Patch |
| Thermal Adhesion PatchAlso: Marketed ThermaCare Thermal Adhesion Patch | Device | Marketed ThermaCare Air Activated Heat Patch |
Primary outcome
Heat Intensity
Time frame: 8 hours
Assessed using sensors.
2 secondary outcomes
Adhesion Evaluation
Time frame: 8 hours
Irritation Evaluation
Time frame: 8 hours
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2020.
- 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.
Albert Q. Tejada, MD principal investigator
Radiant Research, 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 Thermal Adhesion Patch 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 8 inclusion and 13 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: stopped early, as of the sponsor's last update on 12 Aug 2020. 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 was stopped early. Results are not available in the source record.
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?
Heat Intensity (time frame: 8 hours). 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 12 Aug 2020.