Healthy IndividualsNCT01545973
Understanding the Physiological Implications of Scanning Kelvin Probe Measurements
An observational study of Healthy Individuals and Skin Electrical Potential, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effects of skin thickness, skin moisture, and sweat gland density on Scanning Kelvin Probe measurements. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals, Skin Electrical Potential
- What is being tested?
- Skin Moistening, Skin Denuding
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Aug 2012
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Volunteers
Who may be able to join
- "Healthy" is defined as not having a chronic medical condition requiring daily medications (hypertension, diabetes, hypothyroidism, etc)
Who cannot join
- autonomic disorders (sweating irregularities), skin disorders, extensive burns/scars on the hand, tremors, neuromuscular conditions, restless leg syndrome, movement disorders, and implanted cardiac defibrillator/pacemaker
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital - Martinos Center for Biomedical Imaging
Charlestown, Massachusetts, 02129
About this study
Official title: Measuring Skin Electrical Potential With the Kelvin Probe: Underlying Physiology
The purpose of this study is to evaluate the effects of skin thickness, skin moisture, and sweat gland density on Scanning Kelvin Probe measurements.
Read the detailed description
The Scanning Kelvin Probe measures the electrical potential of material surfaces without actually touching it. Although this technology has been applied to non-living materials (e.g. metal and semiconductors) before, it has not been effectively applied to biological materials, much less to live human skin . This project aims to evaluate the use of Scanning Kelvin Probe to live human skin by investigating the effects of skin thickness, skin moisture, and sweat glands on Kelvin Probe measurements of electrical potential. Testing will be performed on the arms and hands of twenty four healthy individuals under different study conditions.
- Conditions
- Healthy Individuals, Skin Electrical Potential
- Being tested
- Skin Moistening, Skin Denuding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin Moistening, Skin DenudingOther
Application of normal saline to skin and Tape stripping of the superficial skin
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Human subjects without chronic medical conditions, defined as conditions requiring chronic medication use. Receives: Other: Skin Moistening, Skin Denuding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surface Electrical Potential
The electrical potential of skin obtained from the Scanning Kelvin Probe
Measured: 1 day
Secondary outcomes (1)
Electrical Impedance
Electrical impedance (measurement) obtained through another, more conventional measurement device.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study startAug 2011
- Primary completionAug 2012 (estimated)
- Study completionAug 2012 (estimated)
Why it stopped: Repair of minor software glitches
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy IndividualsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew A. Ahn, Massachusetts General Hospital
- Investigators
- Andrew C. Ahn, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01545973
- Sponsor's protocol ID
- 55R21AT005249-02
- Status last verified
- Mar 2012
- First submitted
- 2 Mar 2012
- Last updated
- 7 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Skin Electrical Potential With the Kelvin Probe: Underlying Physiology
- ClinicalTrials.gov ID
- NCT01545973
- Acronym / sponsor ID
- 55R21AT005249-02
- Conditions
- Healthy Individuals, Skin Electrical Potential
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Repair of minor software glitches
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Aug 2012 (estimated)
- First posted
- 7 Mar 2012 (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.
The purpose of this study is to evaluate the effects of skin thickness, skin moisture, and sweat gland density on Scanning Kelvin Probe measurements.
Detailed description
The Scanning Kelvin Probe measures the electrical potential of material surfaces without actually touching it. Although this technology has been applied to non-living materials (e.g. metal and semiconductors) before, it has not been effectively applied to biological materials, much less to live human skin . This project aims to evaluate the use of Scanning Kelvin Probe to live human skin by investigating the effects of skin thickness, skin moisture, and sweat glands on Kelvin Probe measurements of electrical potential. Testing will be performed on the arms and hands of twenty four healthy individuals under different study conditions.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | Other: Skin Moistening, Skin DenudingHuman subjects without chronic medical conditions, defined as conditions requiring chronic medication use. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Volunteers
Key inclusion criteria (1 listed)
- "Healthy" is defined as not having a chronic medical condition requiring daily medications (hypertension, diabetes, hypothyroidism, etc)
Key exclusion criteria (1 listed)
- autonomic disorders (sweating irregularities), skin disorders, extensive burns/scars on the hand, tremors, neuromuscular conditions, restless leg syndrome, movement disorders, and implanted cardiac defibrillator/pacemaker
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 |
|---|---|---|
| Skin Moistening, Skin DenudingApplication of normal saline to skin and Tape stripping of the superficial skin | Other | Healthy Volunteers |
Primary outcome
Surface Electrical Potential
Time frame: 1 day
The electrical potential of skin obtained from the Scanning Kelvin Probe
1 secondary outcome
Electrical Impedance
Time frame: One day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2012.
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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.
Andrew C. Ahn, MD, MPH principal investigator
Massachusetts General Hospital
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 Individuals and Skin Electrical Potential, run by Massachusetts General Hospital 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 1 inclusion and 1 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: paused, as of the sponsor's last update on 7 Mar 2012. 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?
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?
Surface Electrical Potential (time frame: 1 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 7 Mar 2012.