Effects of HeatNCT01841801
Evaluation of Experimental and Commercial Air-Activated, Adhesive Backed Heat Patches
A study testing Thermal Adhesive Patch and Marketed Thermal Adhesive Patch in people with Effects of Heat and Tolerability, run by Chattem, Inc. at 1 site in United States.
Trial summary
To assess the safety and tolerability for the extended wear of an experimental air-activated self adhesive patch. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Effects of Heat, Tolerability, Adhesiveness
- What is being tested?
- Thermal Adhesive Patch and Marketed Thermal Adhesive Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Dec 2012
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants are 18 to 70 years of age;
- must be in general good health;
- must have absence of any visible disease that might be confused with a skin reaction to the test material;
- back region must be free from excessive hair, cuts, tatoos, or other aberrations;
- must understand and sign Informed Consent;
- must be considered dependable and able to follow directions;
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- Participants assigned to the thermocouples must be willing to restrict their activity for the 8 hour patch wear time so that the thermocouples do not come loose;
- Participants assigned to the thermocouples must be willing to wear a pouch containing the thermostat and thermocouple wiring for the entire 8 hour period and to return all study supplies to the site at visit 15. If the items are not returned subject may be invoiced for the value of the unit;
- must be willing to not wear any topical products such as lotions, sunscreens, etc. in the test area while participating in the study;
- must agree to use an adequate means of birth control which include: abstinence, partner vasectomy, Intrauterine Device, hormonal implant devices/injections, regular use of birth control pills, birth control patches or condoms with a spermicidal agent;
- Participants are willing to come in each day with a CLEAN back;
- Participants who are 55 years of age and older, agree to supply a t-shirt to wear at visit two that can be marked on with a marker, and to use that t-shirt or supply others at the morning visits (visits 4, 6, 8, 10, 12, 14).
Who cannot join
- Participants with known skin sensitivity to adhesion products;
- Participants with any skin abnormality likely to be aggravated by the study material such as dermatological disease or infection, rash, atrophic, fragile, or abnormally dry skin, cuts or abrasions at the treatment site;
- Participants who are pregnant or nursing, oral interview only;
- Participants with diabetes or poor circulation;
- Participants unable to tolerate conditions of protocol;
- Participants viewed by the investigator as not being suitable for the study;
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- Participants who have had active skin cancer including basal cell carcinoma, or other cancer within one year;
- Participants who are currently participating in another clinical trial;
- Participants who routinely use anti-inflammatory medications (within 5 days of study start (81mg aspirin is okay)) or immunosuppressive or antihistamine medications within 3 weeks prior to study start (steroid nose/eye drops are ok);
- Participants who currently use allergy injections;
- Participants with history of severe asthma;
- Participants with active or uncontrolled immunologic disorders i.e. AIDS, HIV positive, systemic lupus erythematosus, rheumatoid arthritis;
- Participants with uncontrolled thyroid disease;
- Participants who 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;
- Participants who have used topical medications at the test sites within the past 14 days;
- Participants who have lower midline abdominal pinnicula which may interfere with heat patch/wrap application and or evaluation;
- Participants who have a pacemaker, defibrillator or other implantable medical device;
- Participants who have allergies to latex, polyethylene, polypropylene, nickel, chromium or aluminum.
Trial locations and contacts
1 site in 1 country.
About this study
To assess the safety and tolerability for the extended wear of an experimental air-activated self adhesive patch.
- Conditions
- Effects of Heat, Tolerability, Adhesiveness, Dermal Irritation
- Being tested
- Thermal Adhesive Patch, Marketed Thermal Adhesive Patch, Placebo Patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal Adhesive PatchDevice
Marketed Thermal Adhesive PatchDevice
Also called ThermaCare Heat Wraps
Placebo PatchDevice
| Study group | Role | What they receive |
|---|---|---|
| Marketed Thermal Adhesive Patch | Active comparator | Group of subjects wearing comparative predicate device for 8 hours daily for 7 days. Receives: Device: Marketed Thermal Adhesive Patch |
| Thermal Adhesive Patch | Experimental | Group of subjects wearing the experimental patch for 8 hours daily for 7 days. Receives: Device: Thermal Adhesive Patch |
| Placebo Patch | Placebo comparator | Group of subjects wearing the placebo patch for 8 hours daily for 7 days. Receives: Device: Placebo Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irritation Evaluation
A trained skin grader will apply a predetermined scale to the observed skin reactions in the test areas under light supplied by a 100-watt incandescent blue bulb.
Measured: 7 days - 8 hours each day
Secondary outcomes (1)
Adhesion Evaluation
Adhesion will be evaluated to a predetermined scale when the subjects return for visits; after approximately 8 hours of wear time.
Measured: after 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study startOct 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of HeatStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chattem, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel J Hogan, MD, Principal investigator, Radiant Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01841801
- Sponsor's protocol ID
- 2012007
- Status last verified
- Apr 2013
- First submitted
- 23 Apr 2013
- 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
- Evaluation of Experimental and Commercial Air-Activated, Adhesive Backed Heat Patches
- ClinicalTrials.gov ID
- NCT01841801
- Acronym / sponsor ID
- 2012007
- Conditions
- Effects of Heat, Tolerability, Adhesiveness, Dermal Irritation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Chattem, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 29 Apr 2013 (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.
To assess the safety and tolerability for the extended wear of an experimental air-activated self adhesive patch.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Marketed Thermal Adhesive Patch | Active comparator | Device: Marketed Thermal Adhesive PatchGroup of subjects wearing comparative predicate device for 8 hours daily for 7 days. |
| Thermal Adhesive Patch | Experimental | Device: Thermal Adhesive PatchGroup of subjects wearing the experimental patch for 8 hours daily for 7 days. |
| Placebo Patch | Placebo comparator | Device: Placebo PatchGroup of subjects wearing the placebo patch for 8 hours daily for 7 days. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participants are 18 to 70 years of age;
- must be in general good health;
- must have absence of any visible disease that might be confused with a skin reaction to the test material;
- back region must be free from excessive hair, cuts, tatoos, or other aberrations;
- must understand and sign Informed Consent;
Key exclusion criteria (18 listed)
- Participants with known skin sensitivity to adhesion products;
- Participants with any skin abnormality likely to be aggravated by the study material such as dermatological disease or infection, rash, atrophic, fragile, or abnormally dry skin, cuts or abrasions at the treatment site;
- Participants who are pregnant or nursing, oral interview only;
- Participants with diabetes or poor circulation;
- Participants unable to tolerate conditions of protocol;
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 Adhesive Patch | Device | Thermal Adhesive Patch |
| Marketed Thermal Adhesive PatchAlso: ThermaCare Heat Wraps | Device | Marketed Thermal Adhesive Patch |
| Placebo Patch | Device | Placebo Patch |
Primary outcome
Irritation Evaluation
Time frame: 7 days - 8 hours each day
A trained skin grader will apply a predetermined scale to the observed skin reactions in the test areas under light supplied by a 100-watt incandescent blue bulb.
1 secondary outcome
Adhesion Evaluation
Time frame: after 8 hours
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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Heat Acclimation and Thermotolerance
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Radiation Hypofractionation Via Extended Versus Accelerated Therapy (HEAT) For Prostate Cancer
Prostate Cancer
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.
Daniel J Hogan, MD principal investigator
Radiant Research
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 Adhesive Patch and Marketed Thermal Adhesive Patch in people with Effects of Heat and Tolerability, 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 12 inclusion and 18 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. Some participants in this study may receive a placebo. 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?
Irritation Evaluation (time frame: 7 days - 8 hours each day). 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.