DermaSensor Study of Primary Care Physician Use of Elastic-Scattering Spectroscopy (ESS) on Skin Lesions Suggestive of Skin Cancer

DERMaSensor Study of Primary Care Physician Use of Elastic-Scattering Spectroscopy (ESS) on Skin Lesions Suggestive of Skin Cancer (DERM-SUCCESS)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06690086

Acronym

DERM-SUCCESS

Enrollment

1028

Registered

2024-11-15

Start date

2020-08-17

Completion date

2021-12-09

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Cancer

Keywords

Melanoma, Basal Cell Carcinoma, Squamous Cell Carcinoma, Elastic Scattering Spectroscopy

Brief summary

The purpose of this study is to evaluate the clinical validity of the proprietary DermaSensor Elastic Scattering Spectroscopy (ESS) device and classifier algorithm to support assessment of skin lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma in the primary care setting.

Detailed description

A prospective, single-arm, blinded, multicenter study conducted at 22 investigational sites in the United States and Australia. Eighteen sites located in the US and four sites located in Australia.

Interventions

PROCEDURELesion biopsy

Lesions enrolled in the study are biopsied to confirm histopathology

DEVICEDermaSensor Device Use

Users are blinded to the DermaSensor Device result

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Men or women of any ethnic group aged 22 and older 2. Primary skin lesion suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma that requires biopsy to assess risk of malignancy 3. Patient is willing and able to read, understand and sign the Informed Consent Form (ICF)

Exclusion criteria

1. Lesion \< 2.5mm in diameter or \> 15mm in diameter 2. Lesion surface not accessible (e.g. inside ears, under nails, completely covered by a crust or scale) 3. Lesion on area of crust, psoriasis, eczema or similar skin condition 4. Lesion has erosion and/or ulceration with no area \>2.5mm intact 5. Lesion has foreign matter (e.g. tattoo, splinter, dermoscopy oils, or other medicated or non-medicated topical solutions) 6. Lesion in which the device tip cannot be placed entirely within the border of the targeted area 7. Lesion located on acral skin (e.g. sole or palms) 8. Lesion located within 1 cm of the eye 9. Lesion on or adjacent to scars, areas previously biopsied, or areas subjected to any past surgical intervention 10. Lesion located on mucosal surfaces (e.g. genitals, lips) 11. Lesion located on acute sunburn 12. Six (6) or more lesions suggestive of melanoma, basal cell carcinoma, and/or squamous cell carcinoma requiring biopsy to assess risk of malignancy 13. Dementia or other neurologic, physical or psychological limitation that would prevent the patient from signing informed consent

Design outcomes

Primary

Measure	Time frame
Sensitivity of DermaSensor for Skin Lesions Suggestive of Melanoma, BCC, and/or SCC	Day 1
Sensitivity + Specificity > 1 for Skin Lesions Suggestive of Melanoma, BCC, and/or SCC	Day 1

Secondary

Measure	Time frame
Non-inferiority of the DermaSensor sensitivity to the performance goal of 90%	Day 1

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026