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Vasoconstriction study with LEO 90100
This study compares the pharmacodynamic activity of LEO 90100 with Dermovate cream, Diprosone ointment, Elocon cream, Locoid ointment and LEO 90100 vehicle using a human skin blanching test
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEO 90100 aerosol foam | Experimental | LEO 90100 calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) aerosol foam Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once. |
|
| Dermoval®/Dermovate® | Active Comparator | Dermoval®/Dermovate® (clobetasol propionate 0.05%) cream Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once. |
|
| Diprosone® | Active Comparator | Diprosone® betamethasone 0.5 mg/g (as dipropionate) ointment Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO 90100 aerosol foam | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean of two visual skin blanching scores for each treatment measured 2 hours after 16 hours application under non-occlusive conditions | 18 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CPCAD | Nice | Cedex | 06202 | France |
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| ID | Term |
|---|---|
| C011175 | betamethasone-17,21-dipropionate |
| D000068656 | Mometasone Furoate |
| C007975 | hydrocortisone-17-butyrate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Elocon® | Active Comparator | Elocon® mometasone furoate 0.1% cream Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once. |
|
| Locoid® | Active Comparator | Locoid® hydrocortisone-17-butyrate 0.1% ointment Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once. |
|
| LEO 90100 foam vehicle | Placebo Comparator | LEO 90100 foam vehicle Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once. |
|
| Dermoval®/Dermovate® | Drug |
|
| Diprosone | Drug |
|
| Elocon | Drug |
|
| Locoid | Drug |
|
| LEO 90100 foam vehicle | Other |
|
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |