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Trial Information

The primary objective of this study to test the hypothesis that, among eligible and
evaluable lesions with central histological reference standard status melanoma or high-grade
lesion, the relative sensitivity ρ comparing enrolling dermatologists after MelaFind use
with enrolling dermatologists if MelaFind were not available is greater than 110%. This
represents a clinically meaningful increase in sensitivity.

The secondary objectives of this study are to evaluate real-world use and safety and
effectiveness of MelaFind in a clinical setting.

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:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Relative sensitivity of enrolling dermatologists after MelaFind use and enrolling dermatologists if MelaFind were not available.

Outcome Time Frame:

5 years

Safety Issue:



United States: Institutional Review Board

Study ID:

Protocol 20111



Start Date:

November 2012

Completion Date:

Related Keywords:

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



Massachusetts General Hospital Boston, Massachusetts  02114-2617
The Johns Hopkins University Baltimore, Maryland  21287
University Hospitals Case Medical Center Cleveland, Ohio  44106
Dermatology Associates of Tallahassee 1707 Riggins Road, Tallahassee, Florida  32308
The Dermatology Group, P.C. Verona, New Jersey  07044