A Vasoconstriction Study With LEO 90100

Phase 1

Completed

• Conditions: Psoriasis Vulgaris
• Interventions: Drug: LEO 90100 Aerosol, foam; Drug: Betamethasone dipropionate in LEO 90100 Aerosol, foam, vehicle; Drug: LEO 90100 Aerosol, foam, vehicle; Drug: Daivobet® ointment; Drug: Dermovate® cream; Drug: Synalar® ointment

• Registration Number: NCT01946386
• Lead Sponsor: LEO Pharma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-11
• Study First Submitted QC: 2013-09-16
• Study First Posted: 2013-09-19
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2015-07
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LEO 90100	Daivobet® ointment	-
LEO 90100	Betamethasone dipropionate in LEO 90100 Aerosol, foam, vehicle	-
LEO 90100	LEO 90100 Aerosol, foam	-
LEO 90100	LEO 90100 Aerosol, foam, vehicle	-
LEO 90100	Dermovate® cream	-
LEO 90100	Synalar® ointment	-

Primary Outcome Measures

Name	Time	Method
Visual assessment of skin blanching (visual score (VS))	06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application	Visual Assessment of Skin Blanching on scores 0 to 4

Secondary Outcome Measures

Name	Time	Method
Change from baseline in colorimetric parameter L* (luminance) at each time point (ΔL*)	06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application	AUC (0-32h) of this change by treatment site will be calculated after subtraction of untreated site change
Change from baseline in colorimetric parameter a* (the red/green balance) at each time point	06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application	Change from baseline in colorimetric parameter. AUC (0-32h) of this change by treatment site will be calculated after subtraction of untreated site change

Trial Locations

Locations (1)

CPCAD, Centre de Pharmacologie Clinique Appliquée à la Dermatologie; 🇫🇷 Nice, France