Teledermatology vs. Face-to-Face Visits in the Follow-Up of Patients With Acne
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Teledermatology
Face-to-face consultation
Sponsored by
About this trial
This is an interventional health services research trial for Acne Vulgaris focused on measuring acne, telemedicine, teledermatology
Eligibility Criteria
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
Sites / Locations
- Department of dermatology, University Hospital Inselspital, Bern
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Teledermatology
Face-to-face consultation
Arm Description
Outcomes
Primary Outcome Measures
Total time spent by dermatologist after baseline
Total cumulative time spent by dermatologist for face-to-face consultations or online assessments after baseline.
Secondary Outcome Measures
Total time spent by patient after baseline
Total cumulative time spent by patient for visit-related travels and/or online procedures after baseline.
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.
Number of therapies prescribed for acne
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.
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.
Full Information
NCT ID
NCT04593004
First Posted
October 9, 2020
Last Updated
August 29, 2022
Sponsor
Insel Gruppe AG, University Hospital Bern
1. Study Identification
Unique Protocol Identification Number
NCT04593004
Brief Title
Teledermatology vs. Face-to-Face Visits in the Follow-Up of Patients With Acne
Official Title
Randomized Open-Label Trial Comparing Teledermatology vs. Face-to-Face Consultation in the Follow-Up of Patients With Mild-to-Moderate Acne
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 7, 2020 (Actual)
Primary Completion Date
June 20, 2022 (Actual)
Study Completion Date
June 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
acne, telemedicine, teledermatology
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 stratified random allocation
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Teledermatology
Arm Type
Experimental
Arm Title
Face-to-face consultation
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Teledermatology
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Face-to-face consultation
Intervention Description
Patients will be assessed and followed-up by trained physicians through regular face-to-face outpatient consultations.
Primary Outcome Measure Information:
Title
Total time spent by dermatologist after baseline
Description
Total cumulative time spent by dermatologist for face-to-face consultations or online assessments after baseline.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Total time spent by patient after baseline
Description
Total cumulative time spent by patient for visit-related travels and/or online procedures after baseline.
Time Frame
4 months
Title
Acne severity improvement
Description
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.
Time Frame
2, 4 and 6 months
Title
Number of therapies prescribed for acne
Time Frame
2, 4 and 6 months
Title
Patient study satisfaction
Description
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.
Time Frame
6 months
Title
Patient quality of life improvement
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
28 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Hunger, MD
Organizational Affiliation
University Hospital Inselspital, Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of dermatology, University Hospital Inselspital, Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Teledermatology vs. Face-to-Face Visits in the Follow-Up of Patients With Acne
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