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Completed

NCT Number: NCT01399970

Use of Mobile Teledermatology in the Care of Acne Patients

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

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Key information

Conditions

Acne Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Dermatology, Medical University of Graz

Graz, 8036, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile Teleconsultation Arm (MTA)

Other

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

Outpatient Consultation Arm (OCA)

Other

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

Primary outcomes

  1. Global evaluation Acne score (GEA)

    Time frame: week 24

    Change from Baseline in the median GEA score at week 24

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Collaborators

  • National Bank of Austria

Registry information

Official study title

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

Acronym: Teleacne

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Jul 22, 2011
Registry last updated
Jan 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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