AcneTeleacneNCT01399970
Use of Mobile Teledermatology in the Care of Acne Patients
A study testing Mobile Teleconsultation Arm (MTA) and Outpatient Consultation Arm (OCA) in people with Acne, run by Medical University of Graz at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 12 to 30 years
- Conditions the study is for
- Acne
- What is being tested?
- Mobile Teleconsultation Arm (MTA) and Outpatient Consultation Arm (OCA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteAustria
- Study dates
- Apr 2011to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Pregnancy or lactation period
- Withdrawal of informed consent
- Non-compliance, failure to comply with protocol requirements
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Dermatology, Medical University of Graz
Graz, Graz, 8036
About this study
Official title: 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
- effectiveness: Global evaluation Acne (GEA) score -response at week 24
- safety: drop out rates and medication side effects
- overall patient satisfaction with acne care and therapy
- overall physician satisfaction with mobile acne care
- Conditions
- Acne
- Being tested
- Mobile Teleconsultation Arm (MTA), Outpatient Consultation Arm (OCA)
- Keywords
- Mobile Teledermatology, Telemedicine, Acne
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Teleconsultation Arm (MTA)Other
Also called MTA, Health Care Service Modality
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)Other
Also called OCA, Health Care Service Modality
Patients will receive routine outpatient care at the clinic according to the treatment guidelines, and will be scheduled for outpatient visits every 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Outpatient Consultation Arm (OCA) | Other | Conventional in Office Care Receives: Other: Outpatient Consultation Arm (OCA) |
| Mobile Teleconsultation Arm (MTA) | Experimental | Mobile Teledermatology Care Receives: Other: Mobile Teleconsultation Arm (MTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global evaluation Acne score (GEA)
Change from Baseline in the median GEA score at week 24
Measured: week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Collaborators
- National Bank of Austria
- Responsible party
- Principal investigator, Rainer Hofmann-Wellenhof, MD, Medical University of Graz
- Investigators
- Rainer Hofmann-Wellenhof, MD, Study director, Department of Dermatology, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01399970
- Sponsor's protocol ID
- 02
- Acronym
- Teleacne
- Status last verified
- Jan 2014
- First submitted
- 27 Apr 2011
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Mobile Teledermatology in the Care of Acne Patients - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01399970
- Acronym / sponsor ID
- Teleacne / 02
- Conditions
- Acne
- Keywords
- Mobile Teledermatology, Telemedicine, Acne
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Collaborators
- National Bank of Austria
- Study start
- Apr 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 22 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- effectiveness: Global evaluation Acne (GEA) score -response at week 24
- safety: drop out rates and medication side effects
- overall patient satisfaction with acne care and therapy
- overall physician satisfaction with mobile acne care
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outpatient Consultation Arm (OCA) | Other | Other: Outpatient Consultation Arm (OCA)Conventional in Office Care |
| Mobile Teleconsultation Arm (MTA) | Experimental | Other: Mobile Teleconsultation Arm (MTA)Mobile Teledermatology Care |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnancy or lactation period
- Withdrawal of informed consent
- Non-compliance, failure to comply with protocol requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Teleconsultation Arm (MTA)Also: MTA, Health Care Service ModalityIn 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 | Mobile Teleconsultation Arm (MTA) |
| Outpatient Consultation Arm (OCA)Also: OCA, Health Care Service ModalityPatients will receive routine outpatient care at the clinic according to the treatment guidelines, and will be scheduled for outpatient visits every 4 weeks. | Other | Outpatient Consultation Arm (OCA) |
Primary outcome
Global evaluation Acne score (GEA)
Time frame: week 24
Change from Baseline in the median GEA score at week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rainer Hofmann-Wellenhof, MD study director
Department of Dermatology, Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Teleconsultation Arm (MTA) and Outpatient Consultation Arm (OCA) in people with Acne, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global evaluation Acne score (GEA) (time frame: week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2014.