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

January 12, 2014 updated by: Rainer Hofmann-Wellenhof, MD, Medical University of Graz

Use of Mobile Teledermatology in the Care of Acne Patients - A Randomized Controlled Trial

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

  1. effectiveness: Global evaluation Acne (GEA) score -response at week 24
  2. safety: drop out rates and medication side effects
  3. overall patient satisfaction with acne care and therapy
  4. overall physician satisfaction with mobile acne care

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Department of Dermatology, Medical University of Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Outpatient Consultation Arm (OCA)
Conventional in Office Care
Other: Outpatient Consultation Arm (OCA)
Patients will receive routine outpatient care at the clinic according to the treatment guidelines, and will be scheduled for outpatient visits every 4 weeks.
Other Names:
  • OCA
  • Health Care Service Modality
Experimental: Mobile Teleconsultation Arm (MTA)
Mobile Teledermatology Care
Other: Mobile Teleconsultation Arm (MTA)
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.
Other Names:
  • MTA
  • Health Care Service Modality

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global evaluation Acne score (GEA)
Time Frame: week 24
Change from Baseline in the median GEA score at week 24
week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Collaborators

National Bank of Austria

Investigators

  • Study Director: Rainer Hofmann-Wellenhof, MD, Department of Dermatology, Medical University of Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

April 27, 2011

First Submitted That Met QC Criteria

July 20, 2011

First Posted (Estimate)

July 22, 2011

Study Record Updates

Last Update Posted (Estimate)

January 14, 2014

Last Update Submitted That Met QC Criteria

January 12, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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