Comparing a new low-cost skin examination device with standard equipment used in dermatology clinics

Clinical evaluation of the Arclight dermatoscope attachment for primary care skin cancer triage: a prospective diagnostic accuracy study comparing gold-standard dermatoscopes and Arclight dermatoscope assessments in adults referred to NHS Fife dermatology clinics (Arclight CADET study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN74344082

Enrollment

188

Registered

2026-06-19

Start date

2026-08-19

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Assessment of skin lesions in adults attending dermatology clinics for specialist evaluation. Skin and Connective Tissue Diseases

Interventions

Participants attending NHS Fife dermatology clinics with skin lesions requiring assessment will be invited to take part. Following informed consent, participants will undergo dermoscopic examination u

Eligibility

Sex/Gender

All

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Adults aged 18 years or older 2. Referred to NHS Fife dermatology clinics for assessment of suspicious skin lesions through standard NHS referral pathways 3. Capable of providing written informed consent prior to any study procedures 4. Able and willing to comply with study procedures, including dermoscopic examination and dermoscopic imaging

Exclusion criteria

Exclusion criteria: 1. Inability to provide informed consent, e.g. due to cognitive impairment or language barriers without suitable interpreter support 2. Children or young people (<18 years), as the present study is designed for adult referral pathways 3. Lesions deemed clinically inappropriate for dermoscopic examination by the attending dermatologist

Design outcomes

Primary

Measure	Time frame
Intervention decision concordance between Arclight and gold-standard dermatoscopes measured using Intervention required versus not required (binary outcome); proportion concordant and absolute percentage difference in intervention decisions at Single assessment at dermatology clinic visit (baseline)	—

Secondary

Measure	Time frame
Inter-rater agreement for image reviews measured using Kappa statistic at During blinded image review sessions following completion of image acquisition;Clinician confidence ratings measured using Confidence rating on a 1–10 scale (=6 classified as confident) at Immediately after each lesion examination in clinic;Usability and acceptability measured using Clinician questionnaire and qualitative feedback at Clinician feedback collected at study close-out	—

Measure

Time frame

Inter-rater agreement for image reviews measured using Kappa statistic at During blinded image review sessions following completion of image acquisition;Clinician confidence ratings measured using Confidence rating on a 1–10 scale (=6 classified as confident) at Immediately after each lesion examination in clinic;Usability and acceptability measured using Clinician questionnaire and qualitative feedback at Clinician feedback collected at study close-out

—

Countries

Scotland, United Kingdom

Contacts

Public ContactHelena Feasey

hraf1@st-andrews.ac.uk+44 1334 463599

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 3, 2026