Pigmented Skin Lesion of Uncertain NatureNCT00764920
Skin Imaging With Technologies in Development
An observational study of Pigmented Skin Lesion of Uncertain Nature, run by University of California, Irvine at 1 site in United States.
Trial summary
The purpose of this research is to develop non-invasive imaging modalities for assessment of skin. This is a pilot study which will use multiple imaging modalities to collect information on normal and lesional skin. Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pigmented Skin Lesion of Uncertain Nature
- What is being tested?
- non-invasive imaging modalities for assessment of skin
- Type of treatment
- Medical device
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Study population will be selected from University of California Irvine Medical Clinic
Who may be able to join
- adult male or female 7 and older; able to carry out study instructions
Who cannot join
- Younger than 7 years old
- pregnant woman
- breast feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Beckman Laser Institute Medical Clinic
Irvine, California, 92612
About this study
Official title: Non-invasive Imaging Modalities for Assessment of Normal and Lesional Skin
The purpose of this research is to develop non-invasive imaging modalities for assessment of skin. This is a pilot study which will use multiple imaging modalities to collect information on normal and lesional skin. The researchers understand that the purpose of this study is not to evaluate any particular treatment and an investigation of a new therapeutic intervention would require an additional protocol. Skin conditions to be studied include vascular lesions, pigmentary disorders, inflammatory conditions and neoplasms.
Read the detailed description
Normal and lesional skin will be assessed by the following imaging modalities:
- Laser Speckle Imaging can provide information about relative blood flow in a tissue. In skin it can be used to determine what areas have more blood flow and whether a particular intervention or treatment affects blood flow.
- Optical Coherence Tomography and Optical Doppler Tomography can provide pictures of blood vessels in an area of the body and can also tell how fast blood is flowing in that area.
- Photon Migration Spectroscopy can provide information about the amount of blood, oxygen, fat and water is in a tissue.
- Multi-Spectral Imaging can provide a 3 dimensional image of structures within the skin.
- Multiphoton Microscopy can provide images of structures of the skin.
- Being tested
- non-invasive imaging modalities for assessment of skin
- Keywords
- human skin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive imaging modalities for assessment of skinDevice
skin imaging
| Study group | Role | What they receive |
|---|---|---|
| Skin Imaging | non-invasive imaging modalities for assessment of skin Receives: Device: non-invasive imaging modalities for assessment of skin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect information on normal and lesional skin
Develop non-invasive imaging modalities for assessment of skin.
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pigmented Skin Lesion of Uncertain NatureStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristen Kelly, University of California, Irvine
- Investigators
- Kristen M Kelly, MD, Principal investigator, Beckman Laser Institute University of California Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764920
- Sponsor's protocol ID
- 20086307
- Status last verified
- Aug 2026
- First submitted
- 30 Sep 2008
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Imaging Modalities for Assessment of Normal and Lesional Skin
- ClinicalTrials.gov ID
- NCT00764920
- Acronym / sponsor ID
- 20086307
- Keywords
- human skin
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Oct 2008 (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 research is to develop non-invasive imaging modalities for assessment of skin. This is a pilot study which will use multiple imaging modalities to collect information on normal and lesional skin. The researchers understand that the purpose of this study is not to evaluate any particular treatment and an investigation of a new therapeutic intervention would require an additional protocol. Skin conditions to be studied include vascular lesions, pigmentary disorders, inflammatory conditions and neoplasms.
Detailed description
Normal and lesional skin will be assessed by the following imaging modalities:
- Laser Speckle Imaging can provide information about relative blood flow in a tissue. In skin it can be used to determine what areas have more blood flow and whether a particular intervention or treatment affects blood flow.
- Optical Coherence Tomography and Optical Doppler Tomography can provide pictures of blood vessels in an area of the body and can also tell how fast blood is flowing in that area.
- Photon Migration Spectroscopy can provide information about the amount of blood, oxygen, fat and water is in a tissue.
- Multi-Spectral Imaging can provide a 3 dimensional image of structures within the skin.
- Multiphoton Microscopy can provide images of structures of the skin.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Skin Imaging | – | Device: non-invasive imaging modalities for assessment of skinnon-invasive imaging modalities for assessment of skin |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population will be selected from University of California Irvine Medical Clinic
Key inclusion criteria (1 listed)
- adult male or female 7 and older; able to carry out study instructions
Key exclusion criteria (3 listed)
- Younger than 7 years old
- pregnant woman
- breast feeding
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 |
|---|---|---|
| non-invasive imaging modalities for assessment of skinskin imaging | Device | Skin Imaging |
Primary outcome
Collect information on normal and lesional skin
Time frame: up to 12 weeks
Develop non-invasive imaging modalities for assessment of skin.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
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.
Kristen M Kelly, MD principal investigator
Beckman Laser Institute University of California Irvine
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 Pigmented Skin Lesion of Uncertain Nature, run by University of California, Irvine 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 3 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: under way, not looking for participants, as of the sponsor's last update on 5 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Collect information on normal and lesional skin (time frame: up to 12 weeks). 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 5 Aug 2026.