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Use of Mobile Teledermatology in the Care of Acne Patients (Teleacne)

Primary Purpose

Acne

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Mobile Teleconsultation Arm (MTA)
Outpatient Consultation Arm (OCA)
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acne focused on measuring Mobile Teledermatology, Telemedicine, Acne

Eligibility Criteria

12 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Female or male, aged 12 to 30 years

  • with facial acne
  • requiring systemic isotretinoin treatment (GEA-Score: 3-5)
  • with basic handy skills
  • with a signed consent form

Exclusion Criteria:

  • Pregnancy or lactation period
  • Withdrawal of informed consent
  • Non-compliance, failure to comply with protocol requirements

Sites / Locations

  • Department of Dermatology, Medical University of Graz

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Outpatient Consultation Arm (OCA)

Mobile Teleconsultation Arm (MTA)

Arm Description

Conventional in Office Care

Mobile Teledermatology Care

Outcomes

Primary Outcome Measures

Global evaluation Acne score (GEA)
Change from Baseline in the median GEA score at week 24

Secondary Outcome Measures

Full Information

First Posted
April 27, 2011
Last Updated
January 12, 2014
Sponsor
Medical University of Graz
Collaborators
National Bank of Austria
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1. Study Identification

Unique Protocol Identification Number
NCT01399970
Brief Title
Use of Mobile Teledermatology in the Care of Acne Patients
Acronym
Teleacne
Official Title
Use of Mobile Teledermatology in the Care of Acne Patients - A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Graz
Collaborators
National Bank of Austria

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the present study is to determine whether a mobile teledermatology care model can achieve better clinical outcomes as compared to conventional, outpatient care for the management of severe acne treated with isotretinoin. The superiority of mobile care in comparison to conventional, outpatient care will be investigated regarding effectiveness: Global evaluation Acne (GEA) score -response at week 24 safety: drop out rates and medication side effects overall patient satisfaction with acne care and therapy overall physician satisfaction with mobile acne care

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne
Keywords
Mobile Teledermatology, Telemedicine, Acne

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Outpatient Consultation Arm (OCA)
Arm Type
Other
Arm Description
Conventional in Office Care
Arm Title
Mobile Teleconsultation Arm (MTA)
Arm Type
Experimental
Arm Description
Mobile Teledermatology Care
Intervention Type
Other
Intervention Name(s)
Mobile Teleconsultation Arm (MTA)
Other Intervention Name(s)
MTA, Health Care Service Modality
Intervention Description
In addition to a face-to-face visit at baseline, patients will conduct "mobile visits" at home every two weeks. The general practitioner of choice will perform examinations, such as laboratory or occasionally pregnancy tests every 4 weeks according to the treatment guidelines.
Intervention Type
Other
Intervention Name(s)
Outpatient Consultation Arm (OCA)
Other Intervention Name(s)
OCA, Health Care Service Modality
Intervention Description
Patients will receive routine outpatient care at the clinic according to the treatment guidelines, and will be scheduled for outpatient visits every 4 weeks.
Primary Outcome Measure Information:
Title
Global evaluation Acne score (GEA)
Description
Change from Baseline in the median GEA score at week 24
Time Frame
week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female or male, aged 12 to 30 years with facial acne requiring systemic isotretinoin treatment (GEA-Score: 3-5) with basic handy skills with a signed consent form Exclusion Criteria: Pregnancy or lactation period Withdrawal of informed consent Non-compliance, failure to comply with protocol requirements
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rainer Hofmann-Wellenhof, MD
Organizational Affiliation
Department of Dermatology, Medical University of Graz
Official's Role
Study Director
Facility Information:
Facility Name
Department of Dermatology, Medical University of Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

Use of Mobile Teledermatology in the Care of Acne Patients

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