Trial Outcomes & Findings for At-Home Dermoscopy Artificial Intelligence (NCT NCT05321784)
NCT ID: NCT05321784
Last Updated: 2025-12-29
Results Overview
To analyze layperson Sklip System triage of self-selected pigmented skin lesions of concern (PSLCs) from home with the same or better accuracy than pre-specified performance goals for detection of PSLCs that require biopsy and are malignant: Melanoma and atypical melanocytic nevi with uncertain malignant potential (moderate, severe, and high grade atypia; those with pathology reports that include notes such as: borderline, cannot exclude melanoma, cannot exclude early evolving melanoma, unusual features, atypical spitz nevi, suspicion for melanoma, re-excision (or further removal) should be considered or is recommended in the pathologist management comment) (≥95% sensitivity, ≥30% specificity), Squamous cell carcinoma (≥80% sensitivity, ≥30% specificity), Basal cell carcinoma (≥80% sensitivity, ≥30% specificity). Two-sided 95% confidence intervals for all Sensitivities and Specificities will be calculated using the Exact (Clopper-Pearson) method.
TERMINATED
NA
1 participants
From first day of enrollment to 42 days after first day of enrollment
2025-12-29
Participant Flow
Participant milestones
| Measure |
Self-skin Exam (SSE), Digital Dermoscopy Image (DDI), Sklip System, Full Body Skin Exam (FBSE).
This is a single-arm prospective trial. Participants perform self-skin exams using naked-eye criteria and will take smartphone clinical images (SCI) of each PSL of concern (PSLC). Participants will also take digital dermoscopy images (DDIs) and apply the Sklip System (integrating the Sklip Mole Scan Algorithm (SMSA) to each PSLC of concern in up to 14 days. Within up to 28 days of completing the at-home exams, participants will undergo an in-office visit full body skin exam (FBSE).
Dermoscopy: Take digital dermoscopy images (DDI)
Digital Photography: Take smartphone clinical images (SCI)
Self-Skin Examination: Perform self-skin exam (SSE)
Skin Examination with Sklip: Apply Sklip System
Skin Examination: Undergo in-person full body skin examination (FBSE)
Survey Administration: Ancillary studies
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|---|---|
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Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
At-Home Dermoscopy Artificial Intelligence
Baseline characteristics by cohort
| Measure |
Self-skin Exam (SSE), Digital Dermoscopy Image (DDI), Sklip System, Full Body Skin Exam (FBSE).
n=1 Participants
This is a single-arm prospective trial. Participants perform self-skin exams using naked-eye criteria and will take smartphone clinical images (SCI) of each PSL of concern (PSLC). Participants will also take digital dermoscopy images (DDIs) and apply the Sklip System (integrating the Sklip Mole Scan Algorithm (SMSA) to each PSLC of concern in up to 14 days. Within up to 28 days of completing the at-home exams, participants will undergo an in-office visit full body skin exam (FBSE).
Dermoscopy: Take digital dermoscopy images (DDI)
Digital Photography: Take smartphone clinical images (SCI)
Self-Skin Examination: Perform self-skin exam (SSE)
Skin Examination with Sklip: Apply Sklip System
Skin Examination: Undergo in-person full body skin examination (FBSE)
Survey Administration: Ancillary studies
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=174 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=174 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=174 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=174 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=174 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=174 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=174 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=174 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=174 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=174 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=174 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=174 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=174 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=174 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=174 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=174 Participants
|
PRIMARY outcome
Timeframe: From first day of enrollment to 42 days after first day of enrollmentPopulation: No data was collected for this outcome due to incomplete participation.
To analyze layperson Sklip System triage of self-selected pigmented skin lesions of concern (PSLCs) from home with the same or better accuracy than pre-specified performance goals for detection of PSLCs that require biopsy and are malignant: Melanoma and atypical melanocytic nevi with uncertain malignant potential (moderate, severe, and high grade atypia; those with pathology reports that include notes such as: borderline, cannot exclude melanoma, cannot exclude early evolving melanoma, unusual features, atypical spitz nevi, suspicion for melanoma, re-excision (or further removal) should be considered or is recommended in the pathologist management comment) (≥95% sensitivity, ≥30% specificity), Squamous cell carcinoma (≥80% sensitivity, ≥30% specificity), Basal cell carcinoma (≥80% sensitivity, ≥30% specificity). Two-sided 95% confidence intervals for all Sensitivities and Specificities will be calculated using the Exact (Clopper-Pearson) method.
Outcome measures
Outcome data not reported
Adverse Events
Self-skin Exam (SSE), Digital Dermoscopy Image (DDI), Sklip System, Full Body Skin Exam (FBSE).
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place