At-Home Dermoscopy Artificial Intelligence
This is a new protocol to analyze how the use of the Sklip System enables laypersons to safely triage self-selected pigmented skin lesions of concern (PSLCs) from home with the same or better accuracy than pre-specified performance goals for the detection of PSLCs that require biopsy (Melanoma and atypical melanocytic nevi with uncertain malignant, Squamous cell carcinoma, Basal cell carcinoma). The study protocol will also compare the accuracy of the Sklip System when used by a layperson (Participant) versus near-perfect Sklip System user (Study Coordinator), assess whether Sklip System improves triage of PSLCs \< 6 mm in diameter and triage of thin melanomas with \<0.8 mm Breslow depth as suspicious, as compared to the current medical provider virtual triage method that relies on store-and-forward of smartphone clinical images (SCI), and assess accuracy of layperson-performed self-skin-exams (SSEs) at-home in the identification of all suspicious PSLCs present on their body as compared to the same layperson (Participant) evaluated with a full body skin examination (FBSE) by a dermatology Provider (DP) in-person.
Conditions:
🦠 Malignant Skin Neoplasm
🗓️ Study Start (Actual) 31 January 2025
🗓️ Primary Completion (Estimated) 31 January 2026
✅ Study Completion (Estimated) 31 January 2027
👥 Enrollment (Estimated) 310
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Portland, Oregon, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Participant or legally authorized representative (LAR) must provide written informed consent before any Study-specific procedures or interventions are performed.
    • 2. Age ≥ 21 years with at least one pigmented skin lesion (PSL)/mole on their body. All genders and members of all races and ethnic groups will be included.
    • 3. Participant self-identifies as having Fitzpatrick Skin Type 1 through 4.
    • 4. Participant must be a current or new patient through self-referral or Provider-referral at the participating Study Site.
    • 5. Participant must have access to a smartphone/tablet and be willing to set up virtual communication via direct message to a Study Site dermatology provider (i.e. MyChart in EPIC, direct message in ModMed EMA or other electronic medical record (EMR) type)
    • 6. Participant must be English-speaking due to FDA Breakthrough Designation of the Sklip System in the English language. Therefore, we are unable to accommodate non-English speaking Participants.
    • 7. Participant must be "Healthy", which is defined as someone considered not urgently sick or hospitalized. This will be determined by the Study principle investigator (PI) at each Study Site, a licensed dermatologist, who will be responsible for screening Participants to ensure eligibility criteria is met prior to enrollment.

    Exclusion Criteria:

    • 1. Participant who self-identifies having Fitzpatrick Skin Type 5 or 6.
    • 2. Participant who have had a skin check visit with a dermatology Provider within the last 90 days will be excluded to avoid self-selection bias, unless the Participant identifies a new unexamined (not previously documented) spot of concern.
    • 3. Vulnerable populations including children, prisoners, and decisional impaired adults as well as vision impaired adults will not be eligible for this Study.
    • 4. Pregnant individuals will be excluded in this Study. Since this is a minimal pregnancy risk category, no special precautions will be taken to determine that the patient is not pregnant
Ages Eligible for Study: 21 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 1 April 2022
  • First Submitted that Met QC Criteria 1 April 2022
  • First Posted 11 April 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 17 May 2024
  • Last Update Posted 21 May 2024
  • Last Verified May 2024