A Vasoconstriction Study With LEO 90100

Psoriasis Vulgaris Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01946386
• Other study ID #: LP0053-69
• Status: Completed
• Phase: Phase 1
• Start date: September 2013
• Est. completion date: October 2013

Study information

• Verified date: July 2015
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• LEO 90100 Aerosol, foam
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
• Betamethasone dipropionate in LEO 90100 Aerosol, foam, vehicle

• LEO 90100 Aerosol, foam, vehicle

• Daivobet® ointment

• Dermovate® cream

• Synalar® ointment

Locations

Country	Name	City	State
France	CPCAD, Centre de Pharmacologie Clinique Appliquée à la Dermatologie	Nice

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

France, 

References & Publications (1)

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

Outcome

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

External Links

•   Clinical Trials at LEO Pharma