This trial is active, not recruiting.

Condition skin lesions
Sponsor Orlucent, Inc
Collaborator Clalit Health Services
Start date June 2013
End date June 2017
Trial size 126 participants
Trial identifier NCT02009085, KH 2012


In this study a fluorescent contrast dye is applied to a suspicious skin lesion.

Images are acquired and processed. The information is used to develop a prediction model for the presence of malignant transformation in the skin.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective retrospective
Skin lesions are under suspicion for skin cancer.

Primary Outcomes

Correlation between imaging and pathology.
time frame: No long term follow up is necessary.

Secondary Outcomes

Acute response
time frame: up to 1 day

Eligibility Criteria

All participants at least 18 years old.

Inclusion Criteria: - Over the age of 18 - Individual is scheduled for a skin biopsy in toto - The lesion is pigmented or non pigmented - Lesions may be under suspicion for basal cell carcinoma, squamous cell carcinoma, actinic keratosis, nevi, melanoma, seborrheic keratosis. - The lesion is accessible to the imaging device Exclusion Criteria: - The patient has sensitive skin and easily breaks out in rash - The lesion is within 1 cm of the eye - The lesion is on mucosal surfaces (e.g., lips, genitals) - Pregnant females - Taking medications that pigments the skin

Additional Information

Official title Pilot Study to Asses the Identification of Melanoma in Skin Lesions.
Principal investigator Yehuda Ullmann, MD
Description Images acquired in the study are used for the development of a software analysis program.
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by Orlucent, Inc.