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.

Ectoin Dermatitis Cream 7% as First-line Therapy of Acute Skin Graft Versus Host Disease

Acute Graft Versus Host Disease in Skin

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.

Non-interventional Study to Investigate Treatment Responses to Topical Application With Ectoin Dermatitis Cream 7% as First-line Therapy of Acute Skin GvHD

A trained clinical member of the team scores the degree and severity of skin GvHD as
follow: stage 1, maculopapular rash over <25 percent of body area; stage 2, maculopapular
rash over 25 to 50 percent of body area; stage 3, generalized erythroderma; stage 4,
generalized erythroderma with bullous formation, often with desquamation

The intensity of itching will be graded on a numeric scale, i.e. absent-0, severe-10

The intensity of touch sensitivity will be graded on a numeric scale, i.e. absent-0,
severe-10

The intensity of limited mobility will be graded on a numeric scale, i.e. absent-0,
severe-10

The intensity of pain will be graded on a numeric scale, i.e. absent-0, severe-10

The intensity of wounds will be graded on a numeric scale, i.e. absent-0, severe-10

The intensity of inflammation will be graded on a numeric scale, i.e. absent-0, severe-10

The intensity of erythema will be graded on a 4-point scale, i.e. 0-absent, severe-4

The intensity of dry Skin will be graded on a 4-point scale, i.e. 0-absent, severe-4

The intensity will be graded on a 4-point scale, i.e. 0-absent, severe-4

Cream for symptomatic treatment and relief of skin redness and itching experienced with
various types of inflammatory dermatoses.

Ectoin Dermatitis Cream 7% as First-line Therapy of Acute Skin Graft Versus Host Disease

About this trial

Study ID

Status

Type

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status