SECM Skin Imaging for Skin Diseases

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Open cuts, Skin infection, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

10 Participants Needed

Trial Summary

What is the purpose of this trial?

The aim of this study is to evaluate the imaging performance of Spectrally Encoded Confocal Microscopy (SECM) for imaging human skin and skin diseases.

Research Team

Guillermo Tearney, M.D, PhD.

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for healthy adults over 18 who can give informed consent and have pigmented skin lesions, like moles, on their forearm. It's not open to those unable to consent, with open cuts/sores or infections on the skin, pregnant women, or employees supervised by the investigator.

Inclusion Criteria

I understand the study and can agree to participate.

I have moles on my forearm.

Exclusion Criteria

Pregnant women (according to subject)

I do not have open cuts, skin infections, or contagious skin conditions.

I am unable to give my consent.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Procedure

Participants undergo imaging of skin lesions using a dermatoscope and SECM device

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

Treatment Details

Interventions

• SECM Skin Imaging

Trial Overview The study is testing a new way of looking at human skin using Spectrally Encoded Confocal Microscopy (SECM). The goal is to see how well SECM can image the skin and identify any diseases present in it.

Participant Groups

Group I: SECM Skin Imaging Experimental Treatment 1 Intervention

The SECM skin imaging procedure will be very similar to that by the FDA approved RCM devices. First, the skin lesion (such as a mole) will be identified on a forearm of the subject. The lesion will be imaged first with a dermatoscope, and then with the SECM device. A dermatoscope is a hand-held device used for the visual observation of the epidermis. It is a superior surface contact microscope used to examine skin lesions.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+