Investigation of Sunscreens and Their Efficacy in Patients with Lupus Erythematosus (LE)
Lead Dermatologist: Prof. Annegret Kuhn
Project team members:
Affiliation: Interdisciplinary Center for Clinical Trials University Medical Center, Mainz, Germany, with European Society of Cutaneous Lupus Erythematosus (EUSCLE)
Using the EUSCLE register, this project aims to provide the first data-based sunscreen recommendations for LE patients as a result of an observational study.
Ultraviolet light is an important factor in the pathogenesis of LE. Recent studies demonstrated that sunscreens prevent the induction of disease activity; therefore, sunscreens are a safe and cost-effective preventive option for all patients with the disease, but data-based recommendations on the frequency of application and the type of sunscreen are not yet available. By the means of the existing EUSCLE register of more than 1000 LE patients and a remote data-entry and management system, we aim to collect data in a pan-European observational study, including parameters, e.g. type of sunscreen and its efficacy in the prevention of skin manifestations.
LE can produce considerable morbidity resulting from its manifestations (i.e., disfiguring, painful skin lesions, diffuse and scarring alopecia) and thus, restricts the quality of life in most patients with the disease. To date, it is well known that photosensitivity is a characteristic feature in LE and that UV-exposure can induce and exacerbate skin lesions in patients with LE. Moreover, sun exposure can even lead to life-threatening organ manifestations of LE, underlining the role of preventive measures in the disease.
A vehicle-controlled, randomized, double-blind study by our group demonstrated that the use of a broad-spectrum sunscreen with high UV-protection factor can prevent skin lesions in all photosensitive LE patients. Due to the lack of prospective studies on health care provision for sunscreen protection, definitive conclusions and recommendations about the type and efficacy of sunscreens in LE are not yet available.
Moreover, the refund of sunscreens for patients with photosensitive diseases by the health insurances is still pending in Europe, even though this would be a safe, reasonable and cost-effective alternative to the expensive treatment options. Therefore, it would be of high importance to assess different parameters in LE patients in a pan-European observational study, e.g., the frequency of sunscreen application, the amount of applied sunscreen, the sun protection factor of the applied sunscreen and its efficacy in the prevention of skin lesions. The results of this study will lead to significant improvement of the knowledge and prevention possibilities and to a better quality of life for patients with photosensitive LE.
The European Society of Cutaneous Lupus Erythematosus (EUSCLE) has been initiated in 2004 to foster the awareness, the understanding, and the research of CLE and its best management throughout Europe. Currently, EUSCLE has 206 active members in 41 countries worldwide and 169 active members in 25 European countries. Recently, our group collected and statistically analysed data of 1002 LE patients in 13 European countries, including clinical and laboratory characteristics, as well as therapeutic strategies and their efficacies and published the results in three manuscripts. In the present project, we suggest to address all European EUSCLE centers and send them a link to the web-based questionnaire, which you find submitted as PDF document. The physicians will include data in the remote system encompassing general questions (i.e., gender, age, LE subtype) and detailed questions as photosensitivity, type of applied sunscreens and their efficacy in the prevention of skin manifestations.
In the current research study, we aim to investigate the type of the sunscreens applied by patients with LE and the efficacy of different sunscreens in daily life. Consequently, the main research questions that are addressed by the study are:
- How often do LE patients apply sunscreens?
- Which type of sunscreen is used by LE patients?
- How efficient are sunscreens in daily life to prevent skin lesions in LE patients?
In addition to the type and efficacy of sunscreens with a low, medium, or high protection factor applied by patients with LE, feasible secondary objectives are:
- Patient´s satisfaction and quality of life
- Frequency and severity adverse events (e.g. irritated skin)
The main outcome measures will include different parameters, such as gender, age at onset of disease, photosensitivity, applied type of sunscreen and its efficacy in the prevention of skin manifestations.
The study will be conducted at the Interdisciplinary Center for Clinical Trials (IZKS, http://www.izks-mainz.de), University Medical Center of Mainz, Germany, which has long-term experience with complex data management and which generated a web interface (https://ecct.izks-mainz.de/) for remote data entry and online data management. This web-interface provides innovative features such as automatic tracking of recruitment of patients per center and a modern query management system with automatic plausible checks. The web-interface is also optimized for mobile devices. Therefore, physicians can easily access the database from everywhere in order to view the live data and/or even manage the data.
Data acquisition will be realized by using a web-based version of the questionnaire.
A database will be designed to enable uniform and detailed statistical analysis of the questionnaire. Each parameter will be assigned a specific name in Excel and/or SPSS and a standard coding plan for the numerical values will be developed for the uniform transmission of the data into Excel and/or SPSS; moreover, the data collection basis will be structured to lead to various test application possibilities and enabling different combinations for comparison. All data analyses will be performed by the IZKS after study completion. Statistical programming and analyses will be performed using SAS® (SAS Institute, Cary, NC 27513).
Success criteria and evaluation
This project will be considered successful when at least 500 completed questionnaires have been received by our group. After 12 months, the statistical analysis is performed and a manuscript is published.
An interview with the 2015 SKINPACT Award winner in the Community Leadership category, Expert Panel Award:
Prof. Annegret Kuhn, MD, MBA
“The SKINPACT Award is a great honour and gives my institute and I the opportunity to address the highly important issue of sunscreen protection in patients with lupus erythematosus in a European-wide setting. It helps also to address the challenge for the community in achieving a better insight into preventive and therapeutic strategies and implementation of sunscreen reimbursement by health insurance in Europe in the future.”
Prof Annegret Kuhn, MD, MBA
Interdisciplinary Center for Clinical Trials University Medical Center, Mainz, Germany, with European Society of Cutaneous Lupus Erythematosus (EUSCLE)
What motivated you to submit a project application to the SKINPACT Awards?
In patients with lupus erythematosus, there is a high unmet need to conduct a European-wide survey to collect data on the type of sunscreens and their efficacy in the prevention of skin manifestations. This project has been discussed within my team for a long time; however, accessing funding for such a project was difficult. Recognizing that the SKINPACT Awards Programme covers areas such as patient support, access to care and community education, we realized that our project would be perfectly suitable for this type of support. Therefore, we decided to apply for the SKINPACT Award.
What is your project’s theme?
Prevention is the best treatment – The role of UV protection in patients with lupus erythematosus
After winning the Award and grant, how did you proceed with executing your project?
In cooperation with the self-help organisation LUPUS EUROPE, an umbrella association of 24 national lupus self-help organisations from 22 countries throughout Europe, we drafted, discussed and fine-tuned the ‘patient information’ and the ‘questionnaire’ on sunscreen protection in iterative rounds.
The questionnaire was then pre-tested by physicians and patients who were not involved in its development, by asking them to carefully read the survey and to report any misunderstanding or to notify us of any inappropriate questions. Thereafter, the English language documents were translated by bilingual native speakers into 19 European languages. Moreover, we set up a first online questionnaire via ‘Survey Monkey,’ which will be adapted for each translation.
What are the goals and measures of success for your project?
The aim of this project is to improve knowledge of prevention options and provide a basis for detailed recommendations for patients with photosensitive lupus erythematosus. The results will hopefully contribute to the reimbursement of sunscreens for patients with photosensitive diseases, such as lupus erythematosus, by health insurance. This project will be considered successful when at least 500 completed questionnaires from a minimum of 15 different European countries are received by our group after 12 months, the statistical analysis is performed and a manuscript is published in a peer-reviewed journal.
What stage is your project at today?
The translated documents are currently being validated by experts in lupus erythematosus and bilingual native speakers. The reviewed versions of the documents are incorporated into ‘Survey Monkey’. Moreover, we are developing a paper-based version of the documents for patients without a computer/mobile device and/or internet.
Who is working with you on your project?
The staff at my institute, the Interdisciplinary Study Center for Clinical Trials (IZKS) at the University Medical Center, Johannes Gutenberg University of Mainz (Germany) have worked together to develop the online-version of the questionnaire and will perform the data analysis. The project is organized and coordinated by Aysche Landmann, a long-term member of my research study group. Aysche Landmann has profound expertise in the organization of scientific projects (such as the development of the European Guidelines on Cutaneous Lupus Erythematosus), the coordination of Investigator Initiated Trials and is co-author of several manuscripts.
What would be the impact of your project? How do you think your project will make a difference in the real world setting?
First of all, the project itself will generate awareness of lupus erythematosus and, in particular, the need for sunscreen protection in patients with this photosensitive autoimmune disease. The results of this survey will lead to significant improvement in the knowledge of prevention possibilities and – as a next step – the possibility of developing data-based recommendations on the frequency of application and the type of sunscreen. The project and the resulting publication will hopefully contribute to the reimbursement of sunscreens for patients with photosensitive diseases, such as lupus erythematosus, by health insurance.
What would you say to professionals who wish to apply to the SKINPACT Awards?
I can advise them to develop innovative, interdisciplinary and international projects, which focus on the needs of patients with skin disease and in which no or only limited data are available. The SKINPACT Award is a great chance to receive support for your project and to attract attention to your topic in the community.
Finally, could you give some words of encouragement to inspire those who have ideas and initiatives?
Regardless of your career status, there is always an opportunity to realize new ideas and new concepts in dermatology. If you have an idea, you should define your aim, follow it closely, develop a proposal or procedure and look for the best international team and/or partner, who will support you.
A little bit more about Prof. Kuhn…
"On a typical working day...
my work predominantly includes the coordination and organization of clinical research, including meetings with my staff and colleagues from different clinical and research departments, to discuss and develop new projects from bench to bedside. Moreover, my work focuses on the definition of new diagnostic and therapeutic options for patients with lupus erythematosus and the setting up of new guidelines and targeted therapies…”