HealthyNCT00411606
Normal Values of Facial Thermography
An observational study of Healthy and Allergy, run by West Penn Allegheny Health System at 1 site in United States.
Trial summary
An objective of this study is to standardize temperature values derived from thermograms of the facial region. It is anticipated that the mean temperature of a defined region of interest, such as the eyes, nose, or sinuses, might be useful for future applications. Read more about this study
- Who is it for?
- Ages 7 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Allergy, Allergic Rhinoconjunctivitis
- What is being tested?
- Thermography
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Jul 2008
- Phase
- Observational
- 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 7 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: outpatient subjects at Allegheny General Hospital
Who may be able to join
- Between ages 7 and 70
- No mobility problems
- No restrictions in performing normal activities
- No regular pain or discomfort
- No anxiety or depression
Who cannot join
- Restrictions in performing normal activities
- Regular pain
- Anxiety or Depression
- Mobility problems
Trial locations and contacts
1 site in 1 country.
United States1 site
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
About this study
An objective of this study is to standardize temperature values derived from thermograms of the facial region. It is anticipated that the mean temperature of a defined region of interest, such as the eyes, nose, or sinuses, might be useful for future applications.
The investigators will attempt to determine normal temperature ranges based on participants' age and gender.
Read the detailed description
Medical thermography is a noninvasive technique that allows an examiner to visualize and estimate the temperature of the skin surface. An infrared scanning device is used to convert infrared radiation emitted from the skin surface into electrical impulses that can be captured as an image called a thermogram. During the past 20 years medical thermography has been used to study the pathology in the vascular, muscular, neural and skeletal systems.
An objective of this study is to standardize temperature values derived from thermograms of the facial region. It is anticipated that the mean temperature of a defined region of interest, such as the eyes, nose, or sinuses, might be useful for future applications. This protocol addresses the definition of overall health, symptomology, and anthropometrical features (age, weight, height, body mass index and gender), and what effect, if any, each has on mean temperature. Environmental conditions, mapping procedures, and image evaluations will also be standardized. We will attempt to determine normal temperature ranges based on participants' age and gender. Future use of standardized values will be to assess the severity of rhinoconjunctivitis symptoms being experienced by a subject.
Subjects will make one visit to our clinic. They will be asked to acclimate to room temperature for at least 30 minutes. Subjects are requested not to consume hot drinks or food for at least an hour before imaging and not to use any skin preparations such as creams or talcum powder. A picture of the participant's face will be taken using the thermal camera which will demonstrate the temperature of each facial area of interest.
Please note that participants in this study will take part on a completely voluntary basis. No payment will be provided.
- Conditions
- Healthy, Allergy, Allergic Rhinoconjunctivitis
- Being tested
- Thermography
- Keywords
- Healthy, Allergy, Allergic Rhinoconjunctivitis
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThermographyProcedure or surgery
Subjects will have a picture of their face taken with a thermal camera
| Study group | Role | What they receive |
|---|---|---|
| 1 | Subjects with no allergies Receives: Procedure: Thermography |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionJul 2008
- Study completionJul 2008
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Penn Allegheny Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Greer Laboratories
- Investigators
- David Skoner, MD, Principal investigator, West Penn Allegheny Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00411606
- Sponsor's protocol ID
- RC - 4220
- Status last verified
- Apr 2009
- First submitted
- 12 Dec 2006
- Last updated
- 6 Apr 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Values of Facial Thermography
- ClinicalTrials.gov ID
- NCT00411606
- Acronym / sponsor ID
- RC - 4220
- Conditions
- Healthy, Allergy, Allergic Rhinoconjunctivitis
- Keywords
- Healthy, Allergy, Allergic Rhinoconjunctivitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- West Penn Allegheny Health SystemUniversity, hospital or other
- Collaborators
- Greer Laboratories
- Study start
- Dec 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 14 Dec 2006 (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.
An objective of this study is to standardize temperature values derived from thermograms of the facial region. It is anticipated that the mean temperature of a defined region of interest, such as the eyes, nose, or sinuses, might be useful for future applications.
The investigators will attempt to determine normal temperature ranges based on participants' age and gender.
Detailed description
Medical thermography is a noninvasive technique that allows an examiner to visualize and estimate the temperature of the skin surface. An infrared scanning device is used to convert infrared radiation emitted from the skin surface into electrical impulses that can be captured as an image called a thermogram. During the past 20 years medical thermography has been used to study the pathology in the vascular, muscular, neural and skeletal systems.
An objective of this study is to standardize temperature values derived from thermograms of the facial region. It is anticipated that the mean temperature of a defined region of interest, such as the eyes, nose, or sinuses, might be useful for future applications. This protocol addresses the definition of overall health, symptomology, and anthropometrical features (age, weight, height, body mass index and gender), and what effect, if any, each has on mean temperature. Environmental conditions, mapping procedures, and image evaluations will also be standardized. We will attempt to determine normal temperature ranges based on participants' age and gender. Future use of standardized values will be to assess the severity of rhinoconjunctivitis symptoms being experienced by a subject.
Subjects will make one visit to our clinic. They will be asked to acclimate to room temperature for at least 30 minutes. Subjects are requested not to consume hot drinks or food for at least an hour before imaging and not to use any skin preparations such as creams or talcum powder. A picture of the participant's face will be taken using the thermal camera which will demonstrate the temperature of each facial area of interest.
Please note that participants in this study will take part on a completely voluntary basis. No payment will be provided.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: ThermographySubjects with no allergies |
Who may qualify
- Ages
- 7 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- outpatient subjects at Allegheny General Hospital
Key inclusion criteria (5 listed)
- Between ages 7 and 70
- No mobility problems
- No restrictions in performing normal activities
- No regular pain or discomfort
- No anxiety or depression
Key exclusion criteria (4 listed)
- Restrictions in performing normal activities
- Regular pain
- Anxiety or Depression
- Mobility problems
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 |
|---|---|---|
| ThermographySubjects will have a picture of their face taken with a thermal camera | Procedure or surgery | 1 |
Primary outcome
Not reported in the source record.
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 6 Apr 2009.
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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.
David Skoner, MD principal investigator
West Penn Allegheny Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Allergy, run by West Penn Allegheny Health System 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 5 inclusion and 4 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 6 Apr 2009. 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.
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 6 Apr 2009.