NCT04593004

Brief Summary

Acne vulgaris is a common cutaneous inflammatory condition of sebaceous follicles that can profoundly affect patients' quality of life, especially at a young age. In this context the use of teledermatology can potentially reduce the healthcare costs associated to traditional consultations as well as the costs related to travel and loss of school/working time for the patient, with a clear benefit for the whole community. Since 2016, the Department of Dermatology at Inselspital Hospital in Bern has a portal and a smartphone app for online advice service. Hereby the investigators propose to explicitly investigate the efficacy of this system in reducing healthcare costs as compared to traditional face-to-face consultations, in a cohort of patients with mild-to-moderate acne vulgaris.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 7, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2022

Completed
Last Updated

December 6, 2024

Status Verified

December 1, 2024

Enrollment Period

1.7 years

First QC Date

October 9, 2020

Last Update Submit

December 3, 2024

Conditions

Keywords

acnetelemedicineteledermatology

Outcome Measures

Primary Outcomes (1)

  • Total time spent by dermatologist after baseline

    Total cumulative time spent by dermatologist for face-to-face consultations or online assessments after baseline.

    4 months

Secondary Outcomes (5)

  • Total time spent by patient after baseline

    4 months

  • Acne severity improvement

    2, 4 and 6 months

  • Number of therapies prescribed for acne

    2, 4 and 6 months

  • Patient study satisfaction

    6 months

  • Patient quality of life improvement

    6 months

Study Arms (2)

Teledermatology

EXPERIMENTAL
Device: Teledermatology

Face-to-face consultation

ACTIVE COMPARATOR
Other: Face-to-face consultation

Interventions

Patients will be assessed and followed-up by trained physicians through a store-and-forward system (teledermatology online service - Evita® app), which allows patients to upload pictures of skin areas affected by acne as well as their symptoms or questions related to their disease.

Teledermatology

Patients will be assessed and followed-up by trained physicians through regular face-to-face outpatient consultations.

Face-to-face consultation

Eligibility Criteria

Age18 Years - 28 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Given written informed consent
  • Mild-to-moderate acne as assessed by IGA scale
  • Willingness and ability to adhere the study protocol

You may not qualify if:

  • Need for systemic therapy for acne with Isotretinoin
  • Inability to use the teledermatology system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of dermatology, University Hospital Inselspital, Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Officials

  • Robert Hunger, MD

    Insel Gruppe AG, University Hospital Bern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 1:1 stratified random allocation
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2020

First Posted

October 19, 2020

Study Start

October 7, 2020

Primary Completion

June 20, 2022

Study Completion

June 20, 2022

Last Updated

December 6, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations