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Trial record 18 of 24 for:    Ectoine

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

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ClinicalTrials.gov Identifier: NCT02842372
Recruitment Status : Withdrawn (Study withdrawn due to difficulties in recruiting patients)
First Posted : July 22, 2016
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Bitop AG

Brief 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.

Condition or disease
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.


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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Study Start Date : December 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


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



Primary Outcome Measures :
  1. 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

  2. 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 ]
  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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


Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842372


Locations
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Germany
Department of medicine 5, Haematology and Oncology, University hospital Erlangen
Erlangen, Germany, 91054
Sponsors and Collaborators
Bitop AG
Investigators
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Principal Investigator: Martina Haibach, PhD Universitätsklinikum Erlangen

Publications:
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Responsible Party: Bitop AG
ClinicalTrials.gov Identifier: NCT02842372     History of Changes
Other Study ID Numbers: 2016/EHK02/NIS
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: December 10, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Bitop AG:
Acute Graft Versus Host Disease in Skin
GvHD
Ectoin
Dermatitis
Inflammation of the skin
Topical therapy skin GvHD
Additional relevant MeSH terms:
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Dermatitis
Graft vs Host Disease
Skin Diseases
Immune System Diseases