Skin LesionNCT01771718
Pilot Study on In-vivo Non-invasive Skin Imaging Using Multiphoton Microscopy
An observational study of Skin Lesion, run by University of California, Irvine at 1 site in United States.
Trial summary
The purpose of this pilot study is to employ multiphoton microscopy to non-invasively image in-vivo pigmented and non-pigmented human skin lesions for characterization of their morphologic and functional features. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Skin Lesion
- What is being tested?
- Multiphoton microscopy-based tomograph.
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Dec 2028
- 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 Any age
- 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
- Male or Female all age groups
- Ability to understand and carry out subject instructions
Who cannot join
- Pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mihaela Balu, PhD contact
United States1 site, 1 recruiting
- Recruiting
Beckman Laser Institute Medical Clinic
Irvine, California, 92612
Hanna Kim, 949-824-2251, hhkim3@uci.edu
Kristen Kelly, MD
About this study
Official title: Non-invasive Skin Imaging Using Multiphoton Microscopy
The purpose of this pilot study is to employ multiphoton microscopy to non-invasively image in-vivo pigmented and non-pigmented human skin lesions for characterization of their morphologic and functional features.
Read the detailed description
This study is performed using a multiphoton microscopy-based tomograph (MPTflex) developed by JenLab, GmbH (Germany) and a MPM imaging system developed at BLI: Fast Large Area Multiphoton Exoscope (FLAME) to image non-invasively normal and lesional skin. Skin lesions are imaged by multiphoton microscopy and images are compared to those obtained from histopathology through standard of care processed skin biopsies.
Any biopsies will be performed by the health care provider as a standard of care procedure.
- Conditions
- Skin Lesion
- Being tested
- Multiphoton microscopy-based tomograph.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiphoton microscopy-based tomograph.Device
non-invasive optical biopsy
| Study group | Role | What they receive |
|---|---|---|
| Human skin | Multiphoton microscopy imaging to collect information about changes in skin cells and fibrilar structure. Receives: Device: Multiphoton microscopy-based tomograph. |
What is being measured
The primary outcome is the main question the study is designed to answer.
high-resolution images of skin
The complementary imaging modalities (MPM, MI) will provide insights into a better understanding of the relationship between microscopic and macroscopic properties of the skin.
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2013 (estimated)
- Study startApr 2012
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LesionStudies 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
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Principal investigator, Kristen Kelly, University of California, Irvine
- Investigators
- Kristen Kelly, MD, Principal investigator, Beckman Laser Institute, UCI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01771718
- Sponsor's protocol ID
- 20118494
- Other IDs
- R01EB026705
- Status last verified
- Aug 2026
- First submitted
- 15 Jan 2013
- Last updated
- 31 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 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Skin Imaging Using Multiphoton Microscopy
- ClinicalTrials.gov ID
- NCT01771718
- Acronym / sponsor ID
- 20118494
- Conditions
- Skin Lesion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- Apr 2012
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 18 Jan 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.
The purpose of this pilot study is to employ multiphoton microscopy to non-invasively image in-vivo pigmented and non-pigmented human skin lesions for characterization of their morphologic and functional features.
Detailed description
This study is performed using a multiphoton microscopy-based tomograph (MPTflex) developed by JenLab, GmbH (Germany) and a MPM imaging system developed at BLI: Fast Large Area Multiphoton Exoscope (FLAME) to image non-invasively normal and lesional skin. Skin lesions are imaged by multiphoton microscopy and images are compared to those obtained from histopathology through standard of care processed skin biopsies.
Any biopsies will be performed by the health care provider as a standard of care procedure.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Human skin | – | Device: Multiphoton microscopy-based tomograph.Multiphoton microscopy imaging to collect information about changes in skin cells and fibrilar structure. |
Who may qualify
- 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 (2 listed)
- Male or Female all age groups
- Ability to understand and carry out subject instructions
Key exclusion criteria (1 listed)
- Pregnant women
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 |
|---|---|---|
| Multiphoton microscopy-based tomograph.non-invasive optical biopsy | Device | Human skin |
Primary outcome
high-resolution images of skin
Time frame: up to 12 months
The complementary imaging modalities (MPM, MI) will provide insights into a better understanding of the relationship between microscopic and macroscopic properties of the 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 31 Aug 2026.
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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.
Mihaela Balu, PhD contact
Kristen Kelly, MD principal investigator
Beckman Laser Institute, UCI
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 Skin Lesion, 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 2 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: looking for participants now, as of the sponsor's last update on 31 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?
Contact Hanna Kim (949-824-2251, hhkim3@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
high-resolution images of skin (time frame: up to 12 months). 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 31 Aug 2026; AzTrials last refreshed its copy on 31 Oct 2026.