Effects of HeatNCT01841788
Evaluation of Experimental Heat Patch
A study testing Thermal Adhesion Patch and Marketed Thermal Adhesion Patch in people with Effects of Heat and Tolerability, run by Chattem, Inc. at 1 site in United States.
Trial summary
A disposable, air-activated, adhesive backed heat patch is being developed to provide temporary relief from minor muscular ache and joint pains associated with overexertion strains and sprains as well as minor pain associated with arthritis. 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 Adhesion Patch and Marketed Thermal Adhesion Patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Oct 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 18-70 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;
- Participant's back region must be free of excessive hair, cuts, tattoos, or other aberrations;
- must understand and sign Informed Consent;
- must be considered dependable and able to follow directions;
Show all 12Show fewer
- must be willing to restrict their activity for the 8 hour patch wear time so that the patches/thermocouples do not come loose;
- 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 3. If the items are not returned subject may be invoiced for the value of the unit;
- must be willing not to use any topical products such as lotions, sunscreens, etc. in the test area while participating on 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 with a CLEAN back;
- Participants who are 55 years of age or older, agree to supply a t-shirt to wear at visit two that can be marked on with a marker.
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;
Show all 18Show fewer
- 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 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.
United States1 site
Radiant Research, Inc.
Pinellas Park, Florida, 33781
About this study
Official title: Evaluation of Experimental and Commercial Air-Activated, Adhesive Backed Heat Patches
A disposable, air-activated, adhesive backed heat patch is being developed to provide temporary relief from minor muscular ache and joint pains associated with overexertion strains and sprains as well as minor pain associated with arthritis. The aim of the study is to determine the safety and tolerability of the patch during normal wear conditions.
- Conditions
- Effects of Heat, Tolerability, Adhesiveness, Dermal Irritation
- Being tested
- Thermal Adhesion Patch, Marketed Thermal Adhesion Patch, Placebo Patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal Adhesion PatchDevice
Marketed Thermal Adhesion PatchDevice
Also called ThermaCare Heat Wraps
Placebo PatchDevice
| Study group | Role | What they receive |
|---|---|---|
| Thermal Adhesion Patch | Experimental | Group of subjects wearing the experimental patch for 8 hour study duration Receives: Device: Thermal Adhesion Patch |
| Marketed Thermal Adhesion Patch | Active comparator | Group of subjects wearing comparative predicate device for 8 hour study duration. Receives: Device: Marketed Thermal Adhesion Patch |
| Placebo Patch | Placebo comparator | Group of subjects wearing the placebo patch for 8 hour study duration 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: 8 hours
Secondary outcomes (1)
Adhesion Evaluation
Adhesion will be evaluated to a predetermined scale when the subjects return for visit 3 after approximately 8 hours of wear time.
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 posted29 Apr 2013 (estimated)
- Study startOct 2012
- Primary completionOct 2012
- Study completionOct 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
- 40 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
- NCT01841788
- Sponsor's protocol ID
- 2012006
- 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
- NCT01841788
- Acronym / sponsor ID
- 2012006
- Conditions
- Effects of Heat, Tolerability, Adhesiveness, Dermal Irritation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Chattem, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 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.
A disposable, air-activated, adhesive backed heat patch is being developed to provide temporary relief from minor muscular ache and joint pains associated with overexertion strains and sprains as well as minor pain associated with arthritis. The aim of the study is to determine the safety and tolerability of the patch during normal wear conditions.
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 |
|---|---|---|
| Thermal Adhesion Patch | Experimental | Device: Thermal Adhesion PatchGroup of subjects wearing the experimental patch for 8 hour study duration |
| Marketed Thermal Adhesion Patch | Active comparator | Device: Marketed Thermal Adhesion PatchGroup of subjects wearing comparative predicate device for 8 hour study duration. |
| Placebo Patch | Placebo comparator | Device: Placebo PatchGroup of subjects wearing the placebo patch for 8 hour study duration |
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 18-70 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;
- Participant's back region must be free of excessive hair, cuts, tattoos, 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 Adhesion Patch | Device | Thermal Adhesion Patch |
| Marketed Thermal Adhesion PatchAlso: ThermaCare Heat Wraps | Device | Marketed Thermal Adhesion Patch |
| Placebo Patch | Device | Placebo Patch |
Primary outcome
Irritation Evaluation
Time frame: 8 hours
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: 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
Related trials for Effects of Heat
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder
Not yet recruiting
Thermal Preconditioning in Mastectomy Patients With Immediate Breast Reduction
Breast Reconstruction After Mastectomy
RecruitingObservational study
Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
Cholelithiasis
Recruiting
Testing Interventions to Mitigate the Health Impact of Heatwaves on Primary School Children in Climate-vulnerable Districts of Bangladesh.
Heat Cramps, Heat Rash
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 Adhesion Patch and Marketed Thermal Adhesion 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: 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 17 Mar 2017.