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

This study has been completed.
Sponsor:
Collaborator:
National Bank of Austria
Information provided by (Responsible Party):
Rainer Hofmann-Wellenhof, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01399970
First received: April 27, 2011
Last updated: January 12, 2014
Last verified: January 2014
  Purpose

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

Condition Intervention
Acne
Other: Mobile Teleconsultation Arm (MTA)
Other: Outpatient Consultation Arm (OCA)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Use of Mobile Teledermatology in the Care of Acne Patients - A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Global evaluation Acne score (GEA) [ Time Frame: week 24 ] [ Designated as safety issue: No ]
    Change from Baseline in the median GEA score at week 24


Enrollment: 69
Study Start Date: April 2011
Study Completion Date: January 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01399970

Locations
Austria
Department of Dermatology, Medical University of Graz
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
National Bank of Austria
Investigators
Study Director: Rainer Hofmann-Wellenhof, MD Department of Dermatology, Medical University of Graz
  More Information

No publications provided

Responsible Party: Rainer Hofmann-Wellenhof, MD, Prof. Dr., Medical University of Graz
ClinicalTrials.gov Identifier: NCT01399970     History of Changes
Other Study ID Numbers: 02
Study First Received: April 27, 2011
Last Updated: January 12, 2014
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Graz:
Mobile Teledermatology
Telemedicine
Acne

ClinicalTrials.gov processed this record on November 25, 2014