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| ID | Type | Description | Link |
|---|---|---|---|
| 0010287 | Registry Identifier | DIMDI |
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This study evaluates the efficacy of the topical used ectoine-formulation EHK02-01 compared to Atopiclair. Patients are examined at visit 2 (baseline visit). The patient topically applies EHK02-01 or Zarzenda® twice daily on two symmetric lesional areas over 28 days. Response to therapy is recorded at each visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atopiclair | Active Comparator |
| |
| EHK02-01 | Experimental | Ectoine containing cream |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atopiclair | Device | topical applied cream, twice daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| change of a modified, objective (local) SCORAD | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change of local IGA | 28 days | |
| Change of Pruritus | 28 days | |
| Patient's judgment on efficacy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wolfgang Vanscheidt, Professor | Professor Dr. med Wolfgang Vanscheid (Hautarzt, Allergologie, Phlebologie) | Principal Investigator |
| Tanja Fischer, Dr. | Haut- und Lasercentrum Potsdam | Principal Investigator |
| Martin Miehe, Dr. | Hautarztzentrum Tegel | Principal Investigator |
| Michael Sebastian, Dr. | Facharzt für Dermatologie | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hautarztzentrum Tegel | Berlin | 13507 | Germany | |||
| Hautarztpraxis |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| EHK02-01 | Device | topical applied cream containing 7% ectoine |
|
|
| 28 days |
| AEs during treatment phase | 28 days |
| Physical examination | 28 days |
| Patient's assessment of tolerability and safe | 28 days |
| change of the modified, objective local SCORAD | 7 days |
| Freiburg im Breisgau |
| 79100 |
| Germany |
| Gemeinschaftspraxis Mahlow | Mahlow | 15831 | Germany |
| Haut- und Lasercentrum Potsdam | Potsdam | 14469 | Germany |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |