Use of Mobile Teledermatology in the Care of Acne Patients

NCT01399970 | Completed

• 1 other identifier: 02
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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

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

Conditions

Acne

Keywords

Mobile Teledermatology; Telemedicine; Acne

Outcome Measures

Primary Outcomes (1)

• Global evaluation Acne score (GEA)

  Change from Baseline in the median GEA score at week 24

  week 24

Study Arms (2)

Outpatient Consultation Arm (OCA)

OTHER

Conventional in Office Care

Other: Outpatient Consultation Arm (OCA)

Mobile Teleconsultation Arm (MTA)

EXPERIMENTAL

Mobile Teledermatology Care

Other: Mobile Teleconsultation Arm (MTA)

Interventions

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.

Also known as: MTA, Health Care Service Modality

Mobile Teleconsultation Arm (MTA)

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.

Also known as: OCA, Health Care Service Modality

Outpatient Consultation Arm (OCA)

Eligibility Criteria

• Age: 12 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Graz: lead
• National Bank of Austria: collaborator

Study Sites (1)

Department of Dermatology, Medical University of Graz

Graz, Graz, 8036, Austria

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Pemetrexed

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Rainer Hofmann-Wellenhof, MD

  Department of Dermatology, Medical University of Graz

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: April 27, 2011
• First Posted: July 22, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2013
• Last Updated: January 14, 2014

Record last verified: 2014-01

Locations

AU (1)