Psoriasis Vulgaris Clinical Trial
Verified date | July 2015 |
Source | LEO Pharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 35 |
Est. completion date | October 2013 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Following verbal and written information about the trial, the subject must provide signed and dated informed consent before any study related activities are carried out. - Healthy male or female volunteers, 18 to 50 years old, both inclusive Exclusion Criteria: - Female subjects who are pregnant or who are breast feeding. - Abnormal pigmentation of the skin or skin type that could, in any way, confound interpretation of the study results (skin type V and VI on the Fitzpatrick scale) |
Country | Name | City | State |
---|---|---|---|
France | CPCAD, Centre de Pharmacologie Clinique Appliquée à la Dermatologie | Nice |
Lead Sponsor | Collaborator |
---|---|
LEO Pharma |
France,
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
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | Change from baseline in colorimetric parameter L* (luminance) at each time point (?L*) | 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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