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This clinical trial is intended to investigate the efficacy and safety of a medical device compared to untreated on patients with quiescent atopic dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BAY987534 (Treated Arm) | Experimental | Subjects with quiescent atopic dermatitis. Right or left volar forearm with test product applied. |
|
| Untreated Arm | No Intervention | Subjects with quiescent atopic dermatitis. Right or left volar forearm without test product applied. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY987534 | Device | Form: cream; Route of Administration: topical; Frequency of Administration: twice daily ; Duration of Treatment: 4 weeks . |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC of the skin hydration assessed of treatment with the test product compared to untreated | AUC: Area under the curve | Up to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| AUC of the short term skin hydration | Comparison of the test product to untreated | Day 1 |
| Skin hydration by measuring skin capacitance assessed by Corneometry (unit: a.u.) | Comparison of the test product to untreated based on differences to Baseline as well as the comparison to Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| proDerm | Hamburg | 22869 | Germany |
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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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Observer-blind
|
| Up to 4 weeks |
| Skin hydration after treatment by measuring skin capacitance assessed by Corneometry (unit: a.u.) | a.u.: arbitrary units | Up to 4 weeks |
| Skin pH | Comparison of the test product to untreated based on the differences to Baseline | Up to 4 weeks |
| Transepidermal water loss | Comparison of the test product to untreated based on differences to Baseline for SDS (Sodium dodecyl sulfate) unchallenged and SDS challenged skin | Up to 4 weeks |
| Stratum corneum thickness assessed by Raman Spectrometry (unit: µm) | Comparison of the test product to untreated | Up to 8 hours |
| Water gradient within stratum corneum assessed by Raman Spectrometry | Comparison of the test product to untreated | Up to 8 hours |
| Number of participants with adverse events (AEs) | Up to 4 weeks |
| Compliance check | The diaries will be collected and checked for compliance and completeness of the daily record | Day 29 |
| Water content within stratum corneum assessed by Raman Spectrometry (unit: %) | Comparison of the test product to untreated | Up to 8 hours |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |