NCT04060160

Brief Summary

This study is to create a self-learning software that can detect acne lesions. Patients take a picture of their face every single day for 3 months with a secure mobile phone and fill out a pre-designed questionnaire. After 3 months, the mobile will be collected back and the pictures will be evaluated by 3 dermatologists. The software is able to learn from the dermatologists' evaluation and -using machine learning- a mechanism that should be able to automatically detect acne to some extent will be established.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 15, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 16, 2019

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 29, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

January 15, 2025

Status Verified

January 1, 2025

Enrollment Period

3.9 years

First QC Date

August 15, 2019

Last Update Submit

January 13, 2025

Conditions

Keywords

machine learningself-learning softwareimage-detecting software

Outcome Measures

Primary Outcomes (1)

  • Pictures to train the AcneDect software

    Collection of pictures to train the AcneDect software to detect change in acne lesions

    every single day from baseline for 3 months

Secondary Outcomes (1)

  • AcneDect questionnaire regarding acne burden (Visual Analogue Scale (VAS) scale ranging from "Not bad at all" to "Very bad")

    every single day from baseline for 3 months

Interventions

Self- learning software that can detect acne lesions from patients who take a picture of their face every single day for 3 months with a secure mobile phone.

Collection of patient reported outcomes and clinical data via a mobile electronic case report form

Eligibility Criteria

Age10 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Patients within the consultation service of Dermatologische Klinik, Universitätsspital Basel, that meet the inclusion criteria

You may qualify if:

  • Acne vulgaris

You may not qualify if:

  • Refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Health Care SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Services ResearchHealth PlanningHealth Care Economics and OrganizationsPatient Outcome AssessmentOutcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationHealth Care Evaluation MechanismsPublic HealthEnvironment and Public Health

Study Officials

  • Alexander A. Navarini, Prof. Dr. MD

    Dermatologische Klinik; Universitätshospital Basel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2019

First Posted

August 16, 2019

Study Start

October 29, 2020

Primary Completion

September 30, 2024

Study Completion

September 30, 2024

Last Updated

January 15, 2025

Record last verified: 2025-01

Locations