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OpenTrials
Completed

NCT Number: NCT01946386

A Vasoconstriction Study With LEO 90100

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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Key information

Conditions

Psoriasis Vulgaris

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CPCAD, Centre de Pharmacologie Clinique Appliquée à la Dermatologie

Nice, 06202, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Betamethasone dipropionate in LEO 90100 Aerosol, foam, vehicle

Drug

LEO 90100 Aerosol, foam, vehicle

Drug

Daivobet® Ointment

Drug

Dermovate® cream

Drug

Synalar® ointment

Drug

Primary outcomes

  1. Visual assessment of skin blanching (visual score (VS))

    Time frame: 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 outcomes

  1. Change from baseline in colorimetric parameter a* (the red/green balance) at each time point

    Time frame: 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

  2. Change from baseline in colorimetric parameter L* (luminance) at each time point (ΔL*)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 19, 2013
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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