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

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.

Study Overview

• Status: Withdrawn
• Conditions: Acute Graft Versus Host Disease in Skin

Detailed Description

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• Germany
  • Erlangen, Germany, 91054
    • Department of medicine 5, Haematology and Oncology, University hospital Erlangen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with acute skin GvHD grade I (stage 1 or 2) who have either a hypersensitivity to corticosteroids or who are characterized by an ineffectiveness of topical corticosteroids.

Description

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.)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Ectoin Dermatitis Cream 7%; Cream for symptomatic treatment and relief of skin redness and itching experienced with various types of inflammatory dermatoses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in severity of skin GvHD as assessed by a visual examination and asking the patient about pain and discomfort	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	Visit 1 (day 0), Visit 2 (after 7±2 days), Visit 3 (after 14±2 days)
The number of patients who progress within 14 days of initiation of Ectoin treatment		14 days after starting treatment with Ectoin Dermatitis Cream
Change in intensity of itching by using a patient-reported experience questionnaire	The intensity of itching will be graded on a numeric scale, i.e. absent-0, severe-10	Visit 1 (day 0), Visit 2 (after 7±2 days), Visit 3 (after 14±2 days)
Change in Evaluation of touch sensitivity by using a patient-reported experience questionnaire	The intensity of touch sensitivity will be graded on a numeric scale, i.e. absent-0, severe-10	Visit 1 (day 0), Visit 2 (after 7±2 days), Visit 3 (after 14±2 days)
Change in Evaluation of limited mobility by using a patient-reported experience questionnaire	The intensity of limited mobility will be graded on a numeric scale, i.e. absent-0, severe-10	Visit 1 (day 0), Visit 2 (after 7±2 days), Visit 3 (after 14±2 days)
Change in Evaluation of pain by using a patient-reported experience questionnaire	The intensity of pain will be graded on a numeric scale, i.e. absent-0, severe-10	Visit 1 (day 0), Visit 2 (after 7±2 days), Visit 3 (after 14±2 days)
Change in Evaluation of wounds by using a patient-reported experience questionnaire	The intensity of wounds will be graded on a numeric scale, i.e. absent-0, severe-10	Visit 1 (day 0), Visit 2 (after 7±2 days), Visit 3 (after 14±2 days)
Change in Evaluation of inflammation of Skin by using a patient-reported experience questionnaire	The intensity of inflammation will be graded on a numeric scale, i.e. absent-0, severe-10	Visit 1 (day 0), Visit 2 (after 7±2 days), Visit 3 (after 14±2 days)
Change in intensity of erythema evaluated by the physician	The intensity of erythema will be graded on a 4-point scale, i.e. 0-absent, severe-4	Visit 1 (day 0), Visit 2 (after 7±2 days), Visit 3 (after 14±2 days)
Change in Evaluation of dry Skin evaluated by the physician	The intensity of dry Skin will be graded on a 4-point scale, i.e. 0-absent, severe-4	Visit 1 (day 0), Visit 2 (after 7±2 days), Visit 3 (after 14±2 days)
Change in Evaluation of hyperkeratosis evaluated by the physician	The intensity will be graded on a 4-point scale, i.e. 0-absent, severe-4	Visit 1 (day 0), Visit 2 (after 7±2 days), Visit 3 (after 14±2 days)
Change in Evaluation of rhagades evaluated by the physician	The intensity will be graded on a 4-point scale, i.e. 0-absent, severe-4	Visit 1 (day 0), Visit 2 (after 7±2 days), Visit 3 (after 14±2 days)

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	within 14 days after starting treatment with Ectoin Dermatitis Cream

Collaborators and Investigators

• Sponsor: Bitop AG
• Investigators: Principal Investigator: Martina Haibach, PhD, Universitatsklinikum Erlangen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: June 22, 2016
• First Submitted That Met QC Criteria: July 20, 2016
• First Posted (Estimate): July 22, 2016

Study Record Updates

• Last Update Posted (Actual): December 10, 2018
• Last Update Submitted That Met QC Criteria: December 6, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Dermatitis; GvHD; Ectoin; Acute Graft Versus Host Disease in Skin; Inflammation of the skin; Topical therapy skin GvHD
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Dermatitis; Graft vs Host Disease
• Other Study ID Numbers: 2016/EHK02/NIS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided