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

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ClinicalTrials.gov Identifier: NCT04593004
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.


Condition or disease Intervention/treatment Phase
Acne Vulgaris Device: Teledermatology Other: Face-to-face consultation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 1:1 stratified random allocation
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Randomized Open-Label Trial Comparing Teledermatology vs. Face-to-Face Consultation in the Follow-Up of Patients With Mild-to-Moderate Acne
Actual Study Start Date : October 8, 2020
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : August 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Total time spent by patient after baseline [ Time Frame: 4 months ]
    Total cumulative time spent by patient for visit-related travels and/or online procedures after baseline.

  2. Acne severity improvement [ Time Frame: 2, 4 and 6 months ]
    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.

  3. Number of therapies prescribed for acne [ Time Frame: 2, 4 and 6 months ]
  4. Patient study satisfaction [ Time Frame: 6 months ]
    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.

  5. Patient quality of life improvement [ Time Frame: 6 months ]
    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.



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Ages Eligible for Study:   18 Years to 28 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04593004


Contacts
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Contact: Kristine Heidemeyer, MD 316322218 ext +41 Kristine.Heidemeyer@insel.ch

Locations
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Switzerland
Department of dermatology, University Hospital Inselspital, Bern Recruiting
Bern, Switzerland, 3010
Contact: Kristine Heidemeyer, MD    316322218 ext +41    Kristine.Heidemeyer@insel.ch   
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Robert Hunger, MD University Hospital Inselspital, Bern
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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT04593004    
Other Study ID Numbers: 2019-00620
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Inselspital, Berne:
acne
telemedicine
teledermatology
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases