Use of Mobile Teledermatology in the Care of Acne Patients

Acne Clinical Trial

— Teleacne  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01399970
• Other study ID #: 02
• Status: Completed
• Phase: N/A
• First received: April 27, 2011
• Last updated: January 12, 2014
• Start date: April 2011
• Est. completion date: January 2013

Study information

• Verified date: January 2014
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: January 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 30 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Acne

Intervention

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.
• 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.

Locations

Country	Name	City	State
Austria	Department of Dermatology, Medical University of Graz	Graz

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Graz	National Bank of Austria

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global evaluation Acne score (GEA)	Change from Baseline in the median GEA score at week 24	week 24	No