Investigation of Sunscreens and Their Efficacy in Patients with Lupus Erythematosus (LE)

Category

Community Leadership

Lead

Prof. Annegret Kuhn

Affiliation

Interdisciplinary Center for Clinical Trials University Medical Center, Mainz, Germany, with European Society of Cutaneous Lupus Erythematosus (EUSCLE)

Award

Expert Panel Choice

Executive Summary

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.

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The Challenge

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.

Project Overview

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: 

  1. How often do LE patients apply sunscreens?
  2. Which type of sunscreen is used by LE patients?
  3. 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:

  1. Patient´s satisfaction and quality of life
  2. 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).

Project Length

12 months

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.

Video Summary