CompletedNCT00434057Updated Feb 14, 2012Results posted

Evaluation of Pigmented Skin Lesions With MelaFind(R) System

A Phase 3 interventional study of MelaFind(R) in Melanoma, sponsored by MELA Sciences, Inc.. Completed at 2 sites in United States. Per ClinicalTrials.gov, last updated 2012-02-14.

Sponsored by MELA Sciences, Inc. · Phase 3, Interventional, and Diagnostic

Phase: Phase 3
Study type: Interventional
Enrollment: 1,383
Allocation: Non-randomized
Sex: All

Study summary

The purpose of this clinical trial is to demonstrate that MelaFind®, a new instrument that uses machine vision for non-invasive early detection of cutaneous pigmented malignant melanoma, is safe and effective. MelaFind® acquires digital images of the lesion with illumination in different spectral bands, from visible to near infrared, and automatically analyzes these images. Diagnostic accuracy of MelaFind® and that of study dermatologists will be evaluated. The reference standard will be final interpretation of lesions by central dermatohistopathology.

Conditions studied

Melanoma

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Keywords

Pigmented Skin Lesions
Dermatology
Skin Cancer
Melanoma
MelaFind

In context

Melanoma

3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.

This study's enrollment of 1,383 is above the median of 38 across 2,351 interventional studies indexed under Melanoma.

Browse Melanoma studies →

Lead sponsor

MELA Sciences, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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)

Study design

Phase: Phase 3
Primary purpose: Diagnostic
Allocation: Non-randomized
Intervention model: Single group
Masking: None (open label)
Enrollment: 1,383 participants (actual)

Study arms

Other
Biopsied Pigmented Skin Lesions
Pigmented skin lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
Device: MelaFind(R)

Interventions

DeviceMelaFind(R)
Biopsy ratio comparison
Also known as: MF100, MelaFind Device System, MelaFind Device

What researchers measure

Primary outcomes

Sensitivity and Specificity
Sensitivity is the fraction of correctly identified cases of melanoma. Specificity is the fraction of correctly identified cases of non-melanoma.
Time frame: Within 120 days of Data Lock

Secondary outcomes

Biopsy Ratio
Number of lesions bioopsied to melanomas detected
Time frame: Within 120 days of Data Lock
Exploratory Analyses
Time frame: Within 365 days of Data Lock

Results

Posted Nov 11, 2009

Participant flow

Participant flow — Overall Study
Milestone	Biopsied Pigmented Skin Lesions
Started	1383
Completed	1382
Not completed	1
Withdrew: Withdrawal by subject	1

Outcome measures

PrimarySensitivity and Specificity

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

Time frame:: Within 120 days of Data Lock
Reported as:: Mean · Ratio * 100

Sensitivity and Specificity
Ratio * 100	Biopsied Pigmented Skin Lesions
MelaFind sensitivity to melanoma	98.2 (95.1 to 100)
MelaFind specificity for melanoma	9.5 (6.1 to 12.9)

Statistical analysis

Biopsied Pigmented Skin Lesions · exact mid-P · p = 0.05 · Sensitivity to melanoma: 98 · 95% CI 95.1 to 100Of 127 melanomas, 114 melanomas had a pre-biopsy diagnosis of "Melanoma can not be ruled out" or "Not melanoma," which qualified them for primary endpoint analysis of sensitivity. MelaFind correctly identified 112/114 melanomas.
Biopsied Pigmented Skin Lesions · Chi-squared · p = 0.02

SecondaryBiopsy Ratio

Number of lesions bioopsied to melanomas detected

Time frame:: Within 120 days of Data Lock
Reported as:: Number

Results for this outcome have not been posted.

SecondaryExploratory Analyses

Time frame:: Within 365 days of Data Lock

Results for this outcome have not been posted.

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Biopsied Pigmented Skin Lesions	—	0/1,383 (0%)	0/1,383 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Biopsied Pigmented Skin Lesions
<=18 years	56
Between 18 and 65 years	1056
>=65 years	271

Age Continuous
Age Continuous(years)	Biopsied Pigmented Skin Lesions
Mean	48 ± 18.3

Sex: Female, Male
Sex: Female, Male(Participants)	Biopsied Pigmented Skin Lesions
Female	745
Male	638

Region of Enrollment
Region of Enrollment(participants)	Biopsied Pigmented Skin Lesions
United States	1383

Study locations

2 sites

Skin and Cancer Associates
Plantation, Florida 33324, United States
Dermatology Associates of Tallahassee
Tallahassee, Florida 32317, United States

References and documents

Publications

Monheit G, Cognetta AB, Ferris L, Rabinovitz H, Gross K, Martini M, Grichnik JM, Mihm M, Prieto VG, Googe P, King R, Toledano A, Kabelev N, Wojton M, Gutkowicz-Krusin D. The performance of MelaFind: a prospective multicenter study. Arch Dermatol. 2011 Feb;147(2):188-94. doi: 10.1001/archdermatol.2010.302. Epub 2010 Oct 18. PubMed 20956633 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 14, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00434057
Lead sponsor: MELA Sciences, Inc.
Responsible party: Sponsor
First posted: Feb 12, 2007
Start date: Jan 2007
Primary completion: Jul 2008
Completion: Jul 2008
Results posted: Nov 11, 2009
Last update: Feb 14, 2012

Study contacts

Dina Gutkowicz-Krusin, PhD

study director · Electro-Optical Sciences, Inc.

Joseph V Gulfo, MD, MBA

study director · Electro-Optical Sciences, Inc.

Harold S Rabinovitz, MD

study chair · Skin and Cancer Associates

Armand B Cognetta, Jr, MD

study chair · Dermatology Associates of Tallahassee

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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