Acute Graft Versus Host Disease in SkinNCT02842372
Ectoin Dermatitis Cream 7% as First-line Therapy of Acute Skin Graft Versus Host Disease
An observational study of Acute Graft Versus Host Disease in Skin, run by Bitop AG at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Graft Versus Host Disease in Skin
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2015to Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Diagnosis of acute skin graft versus host disease grade I
- hypersensitivity to corticosteroids or ineffectiveness of topical corticosteroids
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of medicine 5, Haematology and Oncology, University hospital Erlangen
Erlangen, 91054
About this study
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.
Read the 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.
- Conditions
- Acute Graft Versus Host Disease in Skin
- Keywords
- Acute Graft Versus Host Disease in Skin, GvHD, Ectoin, Dermatitis, Inflammation of the skin, Topical therapy skin GvHD
- Medical subject headings
- Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ectoin Dermatitis Cream 7% | Cream for symptomatic treatment and relief of skin redness and itching experienced with various types of inflammatory dermatoses. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Visit 1 (day 0), Visit 2 (after 7±2 days), Visit 3 (after 14±2 days)
Secondary outcomes (1)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: within 14 days after starting treatment with Ectoin Dermatitis Cream
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2016 (estimated)
- Study startDec 2015
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Why it stopped: Study withdrawn due to difficulties in recruiting patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Graft Versus Host Disease in SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bitop AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martina Haibach, PhD, Principal investigator, University of Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842372
- Sponsor's protocol ID
- 2016/EHK02/NIS
- Status last verified
- Dec 2018
- First submitted
- 22 Jun 2016
- Last updated
- 10 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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.
PubMed 22533831
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02842372
- Acronym / sponsor ID
- 2016/EHK02/NIS
- Conditions
- Acute Graft Versus Host Disease in Skin
- Keywords
- Acute Graft Versus Host Disease in Skin, GvHD, Ectoin, Dermatitis, Inflammation of the skin, Topical therapy skin GvHD
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study withdrawn due to difficulties in recruiting patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bitop AGIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 22 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ectoin Dermatitis Cream 7% | – | –Cream for symptomatic treatment and relief of skin redness and itching experienced with various types of inflammatory dermatoses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Diagnosis of acute skin graft versus host disease grade I
- hypersensitivity to corticosteroids or ineffectiveness of topical corticosteroids
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in severity of skin GvHD as assessed by a visual examination and asking the patient about pain and discomfort
Time frame: Visit 1 (day 0), Visit 2 (after 7±2 days), Visit 3 (after 14±2 days)
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 number of patients who progress within 14 days of initiation of Ectoin treatment
Time frame: 14 days after starting treatment with Ectoin Dermatitis Cream
Change in intensity of itching by using a patient-reported experience questionnaire
Time frame: Visit 1 (day 0), Visit 2 (after 7±2 days), Visit 3 (after 14±2 days)
The intensity of itching will be graded on a numeric scale, i.e. absent-0, severe-10
Change in Evaluation of touch sensitivity by using a patient-reported experience questionnaire
Time frame: Visit 1 (day 0), Visit 2 (after 7±2 days), Visit 3 (after 14±2 days)
The intensity of touch sensitivity will be graded on a numeric scale, i.e. absent-0, severe-10
Change in Evaluation of limited mobility by using a patient-reported experience questionnaire
Time frame: Visit 1 (day 0), Visit 2 (after 7±2 days), Visit 3 (after 14±2 days)
The intensity of limited mobility will be graded on a numeric scale, i.e. absent-0, severe-10
Change in Evaluation of pain by using a patient-reported experience questionnaire
Time frame: Visit 1 (day 0), Visit 2 (after 7±2 days), Visit 3 (after 14±2 days)
The intensity of pain will be graded on a numeric scale, i.e. absent-0, severe-10
Change in Evaluation of wounds by using a patient-reported experience questionnaire
Time frame: Visit 1 (day 0), Visit 2 (after 7±2 days), Visit 3 (after 14±2 days)
The intensity of wounds will be graded on a numeric scale, i.e. absent-0, severe-10
Change in Evaluation of inflammation of Skin by using a patient-reported experience questionnaire
Time frame: Visit 1 (day 0), Visit 2 (after 7±2 days), Visit 3 (after 14±2 days)
The intensity of inflammation will be graded on a numeric scale, i.e. absent-0, severe-10
Change in intensity of erythema evaluated by the physician
Time frame: Visit 1 (day 0), Visit 2 (after 7±2 days), Visit 3 (after 14±2 days)
The intensity of erythema will be graded on a 4-point scale, i.e. 0-absent, severe-4
Change in Evaluation of dry Skin evaluated by the physician
Time frame: Visit 1 (day 0), Visit 2 (after 7±2 days), Visit 3 (after 14±2 days)
The intensity of dry Skin will be graded on a 4-point scale, i.e. 0-absent, severe-4
Change in Evaluation of hyperkeratosis evaluated by the physician
Time frame: Visit 1 (day 0), Visit 2 (after 7±2 days), Visit 3 (after 14±2 days)
The intensity will be graded on a 4-point scale, i.e. 0-absent, severe-4
Change in Evaluation of rhagades evaluated by the physician
Time frame: Visit 1 (day 0), Visit 2 (after 7±2 days), Visit 3 (after 14±2 days)
The intensity will be graded on a 4-point scale, i.e. 0-absent, severe-4
1 secondary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: within 14 days after starting treatment with Ectoin Dermatitis Cream
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2018.
- Background: PubMed 22533831Dignan 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martina Haibach, PhD principal investigator
University of Erlangen-Nürnberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Graft Versus Host Disease in Skin, run by Bitop AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in severity of skin GvHD as assessed by a visual examination and asking the patient about pain and discomfort (time frame: Visit 1 (day 0), Visit 2 (after 7±2 days), Visit 3 (after 14±2 days)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02842372, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2018.