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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Graft Versus Host Disease in Skin

Keywords

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Acute Graft Versus Host Disease in Skin GvHD Ectoin Dermatitis Inflammation of the skin Topical therapy skin GvHD

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Ectoin Dermatitis Cream 7%

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of acute skin graft versus host disease grade I
* hypersensitivity to corticosteroids or ineffectiveness of topical corticosteroids

Exclusion Criteria

* Grade II-IV GVHD (history of or at time of study entry)
* Use of any systemic steroids at any time for GVHD Treatment
* Non-compliance with medication
* Allergic or otherwise undesirable reaction to Ectoin or any of the other ingredients of the topical cream
* Patients with exanthema of the face
* Pre-existing dermatologic conditions (e.g. eczema, psoriasis, acne etc.)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martina Haibach, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Erlangen

Locations

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Department of medicine 5, Haematology and Oncology, University hospital Erlangen

Erlangen, , Germany

Site Status

Countries

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Germany

References

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Dignan FL, Clark A, Amrolia P, Cornish J, Jackson G, Mahendra P, Scarisbrick JJ, Taylor PC, Hadzic N, Shaw BE, Potter MN; Haemato-oncology Task Force of British Committee for Standards in Haematology; British Society for Blood and Marrow Transplantation. Diagnosis and management of acute graft-versus-host disease. Br J Haematol. 2012 Jul;158(1):30-45. doi: 10.1111/j.1365-2141.2012.09129.x. Epub 2012 Apr 26.

Reference Type BACKGROUND

PMID: 22533831 (View on PubMed)

Other Identifiers

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2016/EHK02/NIS

Identifier Type: -

Identifier Source: org_study_id