Teledermatology vs. Face-to-Face Visits in the Follow-Up of Patients With Acne

Randomized Open-Label Trial Comparing Teledermatology vs. Face-to-Face Consultation in the Follow-Up of Patients With Mild-to-Moderate Acne

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.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Device: Teledermatology; Other: Face-to-face consultation

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Department of dermatology, University Hospital Inselspital, Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 28 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Teledermatology	Device: Teledermatology; 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.
Active Comparator: Face-to-face consultation	Other: Face-to-face consultation; Patients will be assessed and followed-up by trained physicians through regular face-to-face outpatient consultations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total time spent by patient after baseline	Total cumulative time spent by patient for visit-related travels and/or online procedures after baseline.	4 months
Acne severity improvement	Acne severity improvement from baseline as assessed by 5-point ordinal investigator's global assessment (IGA) scale, ranging from 1 to 5, with higher scores indicating a worse outcome.	2, 4 and 6 months
Number of therapies prescribed for acne		2, 4 and 6 months
Patient study satisfaction	Overall patient satisfaction regarding the service received during the study as assessed by 11-point anchored visual analogue scale (VAS), ranging from 0 to 10, with higher scores indicating a better outcome.	6 months
Patient quality of life improvement	Patient quality of life improvement from baseline as assessed by dermatology life quality index (DLQI), ranging from 0 to 30, with higher scores indicating a worse outcome.	6 months

Collaborators and Investigators

• Sponsor: Insel Gruppe AG, University Hospital Bern
• Investigators: Principal Investigator: Robert Hunger, MD, University Hospital Inselspital, Bern

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2020
• Primary Completion (Actual): June 20, 2022
• Study Completion (Actual): June 20, 2022

Study Registration Dates

• First Submitted: October 9, 2020
• First Submitted That Met QC Criteria: October 16, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: telemedicine; acne; teledermatology
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris
• Other Study ID Numbers: 2019-00620

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No