- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03178240
Sunface Mirroring RCT in Brazil
June 2, 2017 updated by: Titus J. Brinker, University of Giessen
Randomized Trial of a Photoaging Mirroring Intervention for Skin Cancer Prevention in Secondary Schools in Brazil - Study Protocol
Randomized trial looking at the effects of a behavioral photoaging software intervention on sunscreen use in the city of Itauna, Brazil.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
1000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
Visiting a secondary school in Brazil.
Exclusion Criteria:
Not visiting a secondary school in Brazil.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
45 minutes seminar on skin cancer prevention and UV-protection in general.
|
selfies of the students are photoaged showing them the consequences of their UV protection behavior on their own face
|
|
No Intervention: Control
The control croup takes part in the survey but does not receive an intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in prevalence of daily sunscreen use at six months
Time Frame: 6 months
|
The difference between daily sunscreen use in the past 30 days in the intervention group from baseline to six months follow-up vs. in the control group from baseline to six months follow-up.
|
6 months
|
|
Change in prevalence of daily sunscreen use at one months
Time Frame: 1 month
|
The difference between daily sunscreen use in the past 30 days in the intervention group from baseline to one months follow-up vs. in the control group from baseline to one month follow-up.
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Brinker TJ, Faria BL, de Faria OM, Klode J, Schadendorf D, Utikal JS, Mons U, Krieghoff-Henning E, Lisboa OC, Oliveira ACC, Lino HA, Bernardes-Souza B. Effect of a Face-Aging Mobile App-Based Intervention on Skin Cancer Protection Behavior in Secondary Schools in Brazil: A Cluster-Randomized Clinical Trial. JAMA Dermatol. 2020 Jul 1;156(7):737-745. doi: 10.1001/jamadermatol.2020.0511.
- Brinker TJ, Faria BL, Gatzka M, de Faria OM, Heppt MV, Kirchberger MC, Schadendorf D, Nakamura Y, Buslaff F, Lisboa OC, Oliveira ACC, Lino HA, Bernardes-Souza B. A skin cancer prevention photoageing intervention for secondary schools in Brazil delivered by medical students: protocol for a randomised controlled trial. BMJ Open. 2018 Mar 6;8(3):e018299. doi: 10.1136/bmjopen-2017-018299.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 1, 2018
Primary Completion (Anticipated)
October 1, 2018
Study Completion (Anticipated)
December 1, 2018
Study Registration Dates
First Submitted
June 2, 2017
First Submitted That Met QC Criteria
June 2, 2017
First Posted (Actual)
June 6, 2017
Study Record Updates
Last Update Posted (Actual)
June 6, 2017
Last Update Submitted That Met QC Criteria
June 2, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SunfaceMirrorBrazil
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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