- Kristina Sophie Ibler, registrar12,
- Gregor B E Jemec, professor1,
- Thomas L Diepgen, professor of dermatology3,
- Christian Gluud, head4,
- Jane Lindschou Hansen, clinical research consultant4,
- Per Winkel, senior researcher4,
- Simon Francis Thomsen, registrar2,
- Tove Agner, professor2
- 1Department of Dermatology, Roskilde Hospital, Health Science Faculty, Køgevej 7-13, 4000 Roskilde, Denmark
- 2Department of Dermatology, Bispebjerg Hospital, Health Science Faculty, Copenhagen, Denmark
- 3Department of Social Medicine, Occupational and Environmental Dermatology, University of Heidelberg, Germany
- 4Copenhagen Trial Unit, Centre for Clinical Intervention Research, Rigshospitalet, Copenhagen University Hospital, Denmark
- Correspondence to: K S Ibler
- Accepted 31 October 2012
Objective To evaluate the effect of a secondary prevention programme with education on skin care and individual counselling versus treatment as usual in healthcare workers with hand eczema.
Design Randomised, observer blinded parallel group superiority clinical trial.
Setting Three hospitals in Denmark.
Participants 255 healthcare workers with self reported hand eczema within the past year randomised centrally and stratified by profession, severity of eczema, and hospital. 123 were allocated to the intervention group and 132 to the control group.
Interventions Education in skin care and individual counselling based on patch and prick testing and assessment of work and domestic related exposures. The control was treatment as usual.
Main outcome measures The primary outcome was clinical severity of disease at five month follow-up measured by scores on the hand eczema severity index. The secondary outcomes were scores on the dermatology life quality index, self evaluated severity of hand eczema, skin protective behaviours, and knowledge of hand eczema from onset to follow-up.
Results Follow-up data were available for 247 of 255 participants (97%). At follow-up, the mean score on the hand eczema severity index was significantly lower (improved) in the intervention group than control group: difference of means, unadjusted −3.56 (95% confidence interval −4.92 to −2.14); adjusted −3.47 (−4.80 to −2.14), both P<0.001 for difference. The mean score on the dermatology life quality index was also significantly lower (improved) in the intervention group at follow-up: difference of means: unadjusted −0.78, non-parametric test P=0.003; adjusted −0.92, −1.48 to −0.37). Self evaluated severity and skin protective behaviour by hand washings and wearing of protective gloves were also statistically significantly better in the intervention group, whereas this was not the case for knowledge of hand eczema.
Conclusion A secondary prevention programme for hand eczema improved severity and quality of life and had a positive effect on self evaluated severity and skin protective behaviour by hand washings and wearing of protective gloves.
Trial registration ClinicalTrials.gov NCT01012453.
Contributors: KSI, TA, and GBJ planned and implemented the trial at different sites. KSI was the main investigator and was responsible for the database. CG and JLH contributed to the original design and were responsible for randomisation and active in the interpretation of the results. TD contributed to the original design of the trial. PW was responsible for the statistical analyses. SFT was helpful in the use of SPSS. KSI drafted the manuscript, which was reviewed by all authors. All authors have approved the final report. KSI, TA, and GBJ are the guarantors of the study.
Funding: This study was funded by Region Zealand’s Research Fund and the Danish Working Environment Research Fund.
Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: GBJ is on the advisory board of Abbott Laboratories and Pfizer, Coloplast and Leo Pharma, in speakers bureau of Galderma and Novartis, and investigator of Actelion, Janssen Pharma and Abbott Laboratories. TD has been a consultant for Spirig Pharma, Basilea Pharmaceutica, Firmenich, Novartis, Procter & Gamble, and Evanik Industries, and in the speakers bureau of Actelion Pharmaceuticals, Almirall, Basilea Pharmaceutica, Leo Pharma, Spirig Pharma, and Astellas. TA is in the speakers bureau of Abbott, Basilea Pharmaceutica, and Leo Pharma. KSI, CG, JLH, PW, and SFT have no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; and no other relationships or activities that could appear to have influenced the submitted work.
Ethical approval: This study was approved by the Danish Research Ethics Committee System for Region Zealand (registration No SJ 126).
Data sharing: No additional data available.
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