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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04593004
• Other study ID #: 2019-00620
• Status: Completed
• Phase: N/A
• Start date: October 7, 2020
• Est. completion date: June 20, 2022

Study information

• Verified date: August 2022
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 20, 2022
• Est. primary completion date: June 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 28 Years

Eligibility

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

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.

Other:
• Face-to-face consultation
Patients will be assessed and followed-up by trained physicians through regular face-to-face outpatient consultations.

Locations

Country	Name	City	State
Switzerland	Department of dermatology, University Hospital Inselspital, Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Number of therapies prescribed for acne		2, 4 and 6 months
Secondary	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
Secondary	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