PJ Coenraads, HC Williams, TL Diepgen, A Svensson, L Naldi
1. To explore study design and quality issues in published clinical trials of interventions for hand-eczema over the past 25 years.
- To describe the range of interventions and comparators
- To describe and comment on the suitability of the main study design types
- To critically appraise the use of disease definitions
- To describe the quality of reporting
- To explore how the abovementioned factors have changed of the 25 year study period
- To make recommendations for improving design and reporting
2. To build a register of published clinical trials on hand-eczema for use in a Cochrane review
Combination of hand-searching and electronic searching for hand-eczema intervention trials in medical journals published in English, German, French, Italian and Dutch language.
Distribution of eligible publications among an expert panel. Assessment of quality in pairs, using a standard data extraction form.
Analysis of the data generated by the data extraction form.
The work is being continued as a Cochrane systematic review.
Hywel C Williams, ┼ke A Svensson, Thomas L Diepgen, Pieter-Jan Coenraads,
Janine Blok, Uwe Matterne. Interventions for hand eczema (Protocol).
Cochrane Database of Systematic Reviews 2002, Issue 3. Art. No.: CD004055.
van Coevorden AM, Coenraads PJ, Svensson A, Bouwes Bavinck JN, Diepgen TL, Naldi L, Elsner P, Williams HC. Overview of studies of treatments for hand eczema ľ the EDEN hand-eczema survey. Br J Dermatol 2004; 151:446-451.
Bauer A, Schmitt J, Bennett C, Coenraads PJ, Elsner P, English J, Williams HC. Interventions for preventing occupational irritant hand dermatitis. Cochrane Database Syst Rev. 2010 Jun 16;(6):CD004414. Review.
Have we missed any trials ?
In List1 you can find the trials (not completely up to date) that were considered for assessment for the abovementioned Cochrane review. In List2 are all the publications up to the end of 2003 that were identified as possible hand-eczema trials.
You are free to use these lists with literature references, provided you acknowledge the hard work that was done by EDEN to assemble these lists.
We would appreciate it if you could notify us if you feel that we have missed a publication dealing with a hand-eczema trial.
To determine the prevalence and severity of contact dermatitis in the general population in Europe and to assess the rate of sensitisation to fragrances and hair-dye, as documented by standard patch test procedures in the same population. This multinational study involves several areas in five European countries (Sweden, Italy, Germany, The Netherlands, Portugal). Subsequent phases of the study are planned to include North American and Asia.
The currently available data is mostly floating numerator data derived from patch test populations with estimates based on patch test reactions as opposed to reactions that are deemed to be clinically relevant and symptomatic. A few epidemiological studies suggest that the point prevalence of contact dermatitis in the general population may vary from 5% to 10% while fragrance sensitization has an expected prevalence of about 1%
A validated questionnaire has been developed to record demographic aspects, clinical history and product exposure. A stratified sampling design will be adopted to select a representative population sample. To collect data, a face-to-face interview will be performed by trained interviewers in the different areas. The sampled subjects will have a patch-test to detect contact allergies.
Current study design:
The pilot phase has been successfully concluded.; the feasibility of the questionnaire and the patch testing wasexamined in a pilot study involving 100 random subjects in each participating center, drawn from the general population registry. The full study in a randomly selected sample from the general population has been started in a number of centers.
Rossi M, Coenraads PJ, Diepgen T, Svensson ┼, Elsner P, Gonšalo M, Bruze M, Naldi L. Design and feasibility of an international study assessing the prevalence of contact allergy to fragrances in the general population: the European Dermato-Epidemiology Network Fragrance Study. Dermatology. 2010;221(3):267-75.
Anecdotally, there is wide variation in treatment approaches between clinicians in the way they treat severe atopic eczema; i.e. eczema that has not responded to conventional topical and/or light therapy. However, no survey has been conducted to confirm this impression.
The TREAT project therefore aims to gather information on how severe atopic eczema in children and adults is treated across Europe, not only to inform clinical practice but also to potentially aid the design of an intervention study with different systemic immuno-suppressive drugs.
The survey among members of Paediatric Dermatology Societies/Interest Groups in 8 countries (Germany, Netherlands, Denmark, Sweden, UK/Ireland, Spain, Italy, and France) has now been completed (n=765). Among the main results were that dermatologists are 4x more likely to use systemic immune-suppressants than paediatricians. Cyclosporin was the first choice medication overall, closely followed by corticosteroids and azathioprine, then MTX. Two publications are planned, one presenting overall European data and one with a more in-depth analysis of the UK cohort.
As a next step, Carsten Flohr is currently seeking funding for a multi-centre RCT with immune-suppressive medication in children with severe atopic eczema.
Jochen Schmitt and Carsten Flohr are still considering toconduct a similar survey re severe AE treatment in adults.