Acute Graft Versus Host Disease in Skin Clinical Trial
Official title:
Non-interventional Study to Investigate Treatment Responses to Topical Application With Ectoin Dermatitis Cream 7% as First-line Therapy of Acute Skin GvHD
This is a non-interventional prospective study to investigate the treatment response to topical application with Ectoin Dermatitis Cream 7% as first-line therapy of grade I acute skin graft-versus-host disease.
Graft-versus-host disease (GvHD) is a medical complication following the receipt of
transplanted tissue from a genetically different person. In the classical sense, acute
graft-versus-host-disease is characterized by selective damage to different organ systems and
the severity of acute GVHD is determined by an assessment of the degree of involvement of the
skin, liver, and gastrointestinal tract.
In general topical steroids can be used as first line treatment in acute grade I skin GvHD
according to Dignan et al 2012. However, the administration of high doses and/or prolonged
use of topical steroids is associated with severe side effects, such as opportunistic
infections, that is a significant factor for morbidity and mortality. Furthermore, the
results of corticosteroid treatment are clearly suboptimal, with continuing complete response
rates of only 20-40% in acute and chronic GVHD. Therefore, it still remains a matter of
debate whether there is an alternative first line therapy to topical steroids that can
overcome these problems.
Ectoin Dermatitis Cream is a high quality cream containing 7% Ectoin without cortisone for
the symptomatic, proactive treatment of atopic dermatitis or other inflammatory skin diseases
as e.g. radio or contact dermatitis. In several clinical studies it has been shown that
Ectoin Dermatitis Cream reduces inflammation of the skin during sub-acute periods and
stabilizes the skin barrier. In acute periods, it reduces the symptoms like itchiness and
redness of the skin.
In this study, Ectoin Dermatitis Cream can be used as therapy of grade 1 (stage 1 and 2)
acute skin GvHD in patients who have a hypersensitivity to corticosteroids or show an
ineffectiveness of topical corticosteroids. Following confirmation of the diagnosis, patients
will asked by the investigator whether they are interested to participate in the current
trial. The investigator, taking the patients into consideration is free to decide who is to
receive the Ectoin Dermatitis Cream.
Patients enrolled in this observational trial will be treated for 14 days with Ectoin
Dermatitis Cream. Patients who do not respond to Ectoin therapy within the first 5 to 7 days
of treatment, will be treated with topical or systemic steroids. However, when there are
indications of good treatment response, the patients will be treated with Ectoin Dermatitis
Cream until symptoms resolve.
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