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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003954-95 | EudraCT Number |
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Investigation aimed to explore the efficacy of a topical Sertaconazole cream 2% in patients with skin alterations associated with atopic dermatitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sertaconazole 2% cream | Active Comparator | 2x daily treatment with Sertaconazole 2% cream for 4 weeks, 2 weeks follow-up |
|
| Placebo Arm | Placebo Comparator | 2x daily treatment with Placebo cream for 4 weeks, 2 weeks follow-up |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sertaconazole 2% cream | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Patient Global Assessment (PGA) | day 1, day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Eczema Area and Severity Index (EASI) | day 1, day 28 | |
| Change in Dermatology Life Quality Index (DLQI) | d1, d28 | |
| Change in Patient Benefit Index (PBI) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Transepidermal water loss (TEWL) | d1, d14, d28, d42 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsmedizin Charité Berlin, Abteilung für Dermatologie und Allergologie | Berlin | 10117 | Germany | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26527564 | Derived | Stander S, Metz M, Ramos F MH, Maurer M, Schoepke N, Tsianakas A, Zeidler C, Luger TA. Anti-pruritic Effect of Sertaconazole 2% Cream in Atopic Dermatitis Subjects: A Prospective, Randomized, Double-blind, Vehicle-controlled, Multi-centre Clinical Trial of Efficacy, Safety and Local Tolerability. Acta Derm Venereol. 2016 Aug 23;96(6):792-6. doi: 10.2340/00015555-2268. |
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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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| ID | Term |
|---|---|
| C061131 | sertaconazole |
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|
| day 1, day 28 |
| Universitätsklinikum Münster, Klinik für Hautkrankheiten |
| Münster |
| 48149 |
| Germany |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |