A Vasoconstriction Study With LEO 90100

March 27, 2019 updated by: LEO Pharma
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06202
        • CPCAD, Centre de Pharmacologie Clinique Appliquée à la Dermatologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: LEO 90100
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
Drug: Betamethasone dipropionate in LEO 90100 Aerosol, foam, vehicle
Drug: LEO 90100 Aerosol, foam, vehicle
Drug: Daivobet® ointment
Drug: Dermovate® cream
Drug: Synalar® ointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application
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
06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LEO Pharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ACTUAL)

October 1, 2013

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

September 11, 2013

First Submitted That Met QC Criteria

September 16, 2013

First Posted (ESTIMATE)

September 19, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 29, 2019

Last Update Submitted That Met QC Criteria

March 27, 2019

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LP0053-69

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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