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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005284-25 | EudraCT Number |
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| Name | Class |
|---|---|
| Adknoma Health Research | INDUSTRY |
| Bayer | INDUSTRY |
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Determine the mean time to itch relief from the start of treatment with topic methylprednisolone aceponate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adventan® (metilprednisolona aceponato 0,1%) | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adventan® (methylprednisolone aceponate 0,1%) | Drug | Doses: 1/4 FTU (Finger Tip Unit) during 5 days (Day 7-Day 11). Procedure: Patch Test (Nickel sulphate 5%) during 2 days (Day 0- Day 2. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean time to Itch Relief (TR) from the start of treatment, with methylprednisolone aceponate. | Time to Itch Relief is defined as the time needed to reach a 30% decrease of the maximum VAS (Visual Analogue Scale used for self-assessment of itch by the volunteers) recorded after the start of treatment. | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Erythema intensity by colorimetry. | 5 days | |
| Eczema intensity by planimetric morphology (ICDRG scale) | 5 days | |
| VAS versus time curve (time to reach VAS max from the start of treatment, AUC, dVAS/dT) |
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Inclusion Criteria:
Criteria for treatment initiation: At day 7, before starting treatment, subjects must meet the inclusion criteria and all the following criteria: ≥ 3 VAS and eczema intensity of (+ +) or (+++) according to ICDRG scale.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Service, Hospital del Mar, Parc de Salut Mar | Barcelona | Barcelona | 08003 | Spain |
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| ID | Term |
|---|---|
| C078007 | methylprednisolone aceponate |
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| 5 days |