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The purpose of this study is to compare the pharmacodynamic activity of LEO 90100 with Dermovate® cream, Dovobet® ointment, betamethasone dipropionate in LEO90100 vehicle, Synalar® ointment and LEO 90100 vehicle using a human skin blanching test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LEO 90100 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LEO 90100 Aerosol, foam | Drug | The products will be applied on 6 test sites (according to random assignment to specific test sites predetermined on their anterior face of forearms) for 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Visual assessment of skin blanching (visual score (VS)) | Visual Assessment of Skin Blanching on scores 0 to 4 | 06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in colorimetric parameter a* (the red/green balance) at each time point | Change from baseline in colorimetric parameter. AUC (0-32h) of this change by treatment site will be calculated after subtraction of untreated site change | 06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Expert | LEO Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CPCAD, Centre de Pharmacologie Clinique Appliquée à la Dermatologie | Nice | 06202 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Queille-Roussel C, Bang B, Clonier F, Lacour JP. Phase I evaluation of the vasoconstrictor potential of an innovative fixed combination calcipotriene plus betamethasone dipropionate aerosol foam versus other corticosteroid psoriasis treatments. J Am Acad Dermatol. 2015:72 Suppl 1;AB243 (P915). |
| Label | URL |
|---|---|
| Clinical Trials at LEO Pharma | View source |
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| ID | Term |
|---|---|
| C011175 | betamethasone-17,21-dipropionate |
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| Betamethasone dipropionate in LEO 90100 Aerosol, foam, vehicle | Drug |
|
| LEO 90100 Aerosol, foam, vehicle | Drug |
|
| Daivobet® ointment | Drug |
|
| Dermovate® cream | Drug |
|
| Synalar® ointment | Drug |
|
| Change from baseline in colorimetric parameter L* (luminance) at each time point (ΔL*) |
AUC (0-32h) of this change by treatment site will be calculated after subtraction of untreated site change |
| 06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application |