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Evaluation of Pigmented Skin Lesions With MelaFind(R) System

Phase 3
Not Enrolling

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Trial Information

Evaluation of Pigmented Skin Lesions With MelaFind(R) System

Inclusion Criteria:

- The lesion is pigmented (i.e., melanin, keratin, blood)

- Clinical management of the lesion by the examining dermatologist is either biopsy of
the lesion in toto, or 3-month follow-up of the lesion

- The diameter of the pigmented area is between 2 and 22 millimeters

- The lesion is accessible to the MelaFind hand-held imaging device

- The patient, or a legally authorized representative, has consented to participate in
the study and has signed the Informed Consent Form

Exclusion Criteria:

- The patient has a known allergy to isopropyl alcohol

- The lesion has been previously biopsied, excised, or traumatized

- The skin is not intact (e.g., open sores, ulcers, bleeding)

- The lesion is within 1 cm of the eye

- The lesion is on mucosal surfaces (e.g., lips, genitals)

- The lesion is on palmar hands

- The lesion is on plantar feet

- The lesion is on or under nails

- The lesion is located on or in an area of visible scarring

- The lesion contains foreign matter (e.g., tattoo, splinter, marker)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Sensitivity and Specificity

Outcome Description:

Sensitivity is the fraction of correctly identified cases of melanoma. Specificity is the fraction of correctly identified cases of non-melanoma.

Outcome Time Frame:

Within 120 days of Data Lock

Safety Issue:


Principal Investigator

Dina Gutkowicz-Krusin, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Electro-Optical Sciences, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

January 2007

Completion Date:

July 2008

Related Keywords:

  • Melanoma
  • Pigmented Skin Lesions
  • Dermatology
  • Skin Cancer
  • Melanoma
  • MelaFind
  • Melanoma
  • Pigmentation Disorders



Skin and Cancer Associates Tamarac, Florida  33309
Dermatology Associates of Tallahassee 1707 Riggins Road, Tallahassee, Florida  32308