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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003485-92 | EudraCT Number |
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 (Cure phase) | Experimental | Efficacy and safety of the medical device Bepanthen Itch Relief Cream in children´s mild AD (responders will enter study phase 2) |
|
| Phase 2 (Care phase) / Arm 1 | Experimental | Efficacy and safety of the new cosmetic Bepanthen test product in maintaining healthy skin in the remission phase after cure of children´s mild AD |
|
| Phase 2 (Care phase) / Arm 2 | Active Comparator | Efficacy and safety of Stelatopia (cosmetic comparator) in maintaining healthy skin in the remission phase after cure of children´s mild AD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bepanthen Itch Relief Cream: Phoenix 2 (Bepanthen Sensiderm, BAY207543) | Device | 2-3 times daily using multiples of Finger Tip Units (FTUs) depending on size of the area of the flares |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: SCORAD with included parameters "extent of disease/area affected" [%] as well as average intensity of pruritus and sleeplessness | up to 3 months | |
| Efficacy: Local SCORAD including single symptoms erythema, edema/ papulation, excoriation, lichenification, oozing/crusts, dryness | up to 3 months | |
| Efficacy: Quality of Life according to questionnaire | up to 3 months | |
| Efficacy: Intensity of pruritus according to diary | up to 3 months | |
| Efficacy: Intensity of sleeplessness according to diary | up to 3 months | |
| Efficacy: Responder rate: No. of subjects with local SCORAD <5 (Phase 1, only) | up to 3 months | |
| Efficacy: Time to flare-up (Phase 2, only) | up to 3 months | |
| Efficacy: Percent of subjects with flare-up (Phase 2, only) | up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Number of adverse events (AE) | up to 3 months | |
| Safety: physical examination | Weight and height | up to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karlsruhe | Baden-Wurttemberg | 76189 | Germany | |||
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| New cosmetic Bepanthen product: Pumpkin (BAY207543) | Other | Twice daily on the whole body; about 10 FTUs (i.e. 5g) per application depending on age of subject |
|
| Stelatopia (cosmetic comparator) | Other | Twice daily on the whole body; about 10 FTUs (i.e. 5g) per application depending on age of subject |
|
| Safety: vital signs |
Systolic and diastolic blood pressure, Heart rate |
| up to 3 months |
| Safety: Local tolerability (by AE assessment) | up to 3 months |
| Kehl |
| Baden-Wurttemberg |
| 77694 |
| Germany |
| Schwäbisch Hall | Baden-Wurttemberg | 74523 | Germany |
| Welzheim | Baden-Wurttemberg | 73642 | Germany |
| Altdorf B. Nürnberg | Bavaria | 90518 | Germany |
| Neustadt / Aisch | Bavaria | 91413 | Germany |
| Rosenheim | Bavaria | 83026 | Germany |
| Bramsche | Lower Saxony | 49565 | Germany |
| Bochum | North Rhine-Westphalia | 44791 | Germany |
| Datteln | North Rhine-Westphalia | 45711 | Germany |
| Dortmund | North Rhine-Westphalia | 44143 | Germany |
| Frankenthal | Rhineland-Palatinate | 67227 | Germany |
| Neumünster | Schleswig-Holstein | 24534 | Germany |
| Erfurt | Thuringia | 99086 | Germany |
| 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 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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