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

NCT02842372 | Withdrawn DMC

• 1 other identifier: 2016/EHK02/NIS
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  within 14 days after starting treatment with Ectoin Dermatitis Cream

Study Arms (1)

Ectoin Dermatitis Cream 7%

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Bitop AG: lead

Study Sites (1)

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

Erlangen, 91054, Germany

Location

Related Publications (1)

• 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.

  PMID: 22533831 BACKGROUND

MeSH Terms

Conditions

Dermatitis

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Martina Haibach, PhD

  Universitätsklinikum Erlangen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2016
• First Posted: July 22, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: December 10, 2018

Record last verified: 2018-12

Locations

DE (1)