Acne VulgarisNCT04593004
Teledermatology vs. Face-to-Face Visits in the Follow-Up of Patients With Acne
A study testing Teledermatology and Face-to-face consultation in people with Acne Vulgaris, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 to 28 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Teledermatology and Face-to-face consultation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Oct 2020to 20 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 28 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Given written informed consent
- Mild-to-moderate acne as assessed by IGA scale
- Willingness and ability to adhere the study protocol
Who cannot join
- Need for systemic therapy for acne with Isotretinoin
- Inability to use the teledermatology system
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of dermatology, University Hospital Inselspital, Bern
Bern, 3010
About this study
Official title: 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.
- Conditions
- Acne Vulgaris
- Being tested
- Teledermatology, Face-to-face consultation
- Keywords
- acne, telemedicine, teledermatology
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeledermatologyDevice
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.
Face-to-face consultationOther
Patients will be assessed and followed-up by trained physicians through regular face-to-face outpatient consultations.
| Study group | Role | What they receive |
|---|---|---|
| Teledermatology | Experimental | Not described Receives: Device: Teledermatology |
| Face-to-face consultation | Active comparator | Not described Receives: Other: Face-to-face consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total time spent by dermatologist after baseline
Total cumulative time spent by dermatologist for face-to-face consultations or online assessments after baseline.
Measured: 4 months
Secondary outcomes (5)
Total time spent by patient after baseline
Total cumulative time spent by patient for visit-related travels and/or online procedures after baseline.
Measured: 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.
Measured: 2, 4 and 6 months
Number of therapies prescribed for acne
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start7 Oct 2020
- Primary completion20 Jun 2022
- Study completion20 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 stratified random allocation
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Hunger, MD, Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04593004
- Sponsor's protocol ID
- 2019-00620
- Other IDs
- 2019
- Status last verified
- Dec 2024
- First submitted
- 9 Oct 2020
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Open-Label Trial Comparing Teledermatology vs. Face-to-Face Consultation in the Follow-Up of Patients With Mild-to-Moderate Acne
- ClinicalTrials.gov ID
- NCT04593004
- Acronym / sponsor ID
- 2019-00620
- Conditions
- Acne Vulgaris
- Keywords
- acne, telemedicine, teledermatology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 20 Jun 2022 (actual)
- Study completion
- 20 Jun 2022 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 stratified random allocation
| Arm | Type | Receives |
|---|---|---|
| Teledermatology | Experimental | Device: Teledermatology |
| Face-to-face consultation | Active comparator | Other: Face-to-face consultation |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Given written informed consent
- Mild-to-moderate acne as assessed by IGA scale
- Willingness and ability to adhere the study protocol
Key exclusion criteria (2 listed)
- Need for systemic therapy for acne with Isotretinoin
- Inability to use the teledermatology system
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeledermatologyPatients 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. | Device | Teledermatology |
| Face-to-face consultationPatients will be assessed and followed-up by trained physicians through regular face-to-face outpatient consultations. | Other | Face-to-face consultation |
Primary outcome
Total time spent by dermatologist after baseline
Time frame: 4 months
Total cumulative time spent by dermatologist for face-to-face consultations or online assessments after baseline.
5 secondary outcomes
Total time spent by patient after baseline
Time frame: 4 months
Acne severity improvement
Time frame: 2, 4 and 6 months
Number of therapies prescribed for acne
Time frame: 2, 4 and 6 months
Patient study satisfaction
Time frame: 6 months
Patient quality of life improvement
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Hunger, MD principal investigator
Insel Gruppe AG, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teledermatology and Face-to-face consultation in people with Acne Vulgaris, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total time spent by dermatologist after baseline (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024; AzTrials last refreshed its copy on 7 Nov 2026.