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Completed

NCT Number: NCT02973776

Vasoconstriction Trial With LEO 90100 Aerosol Foam

Vasoconstriction study with LEO 90100

Completed

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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

Nice, Cedex, 06202, France

About this study

This study compares the pharmacodynamic activity of LEO 90100 with Dermovate cream, Diprosone ointment, Elocon cream, Locoid ointment and LEO 90100 vehicle using a human skin blanching test

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects demonstrating adequate vasoconstriction to Diprosone® ointment within 15 days prior to dosing (unoccluded application of Diprosone® ointment for 4-6 hours must show a visual score of skin blanching of at least one unit (visual scale (0-4)).
  • Subjects without signs of skin irritation/disease/disorders/symptoms or blemishes on test sites (e.g. erythema, dryness, roughness, scaling, scars, moles, sunburn).

Exclusion criteria

  • Abnormal pigmentation of the skin or skin type that could, in any way, confound interpretation of the trial results (skin type V and VI on the Fitzpatrick scale).
  • Female subjects who are breastfeeding.

Treatment and study plan

LEO 90100 aerosol foam

Drug

Dermoval®/Dermovate®

Drug

Diprosone

Drug

Elocon

Drug

Locoid

Drug

LEO 90100 foam vehicle

Other

Primary outcomes

  1. Mean of two visual skin blanching scores for each treatment measured 2 hours after 16 hours application under non-occlusive conditions

    Time frame: 18 hours

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study title

Vasoconstriction Trial Comparing LEO 90100 With Dermovate Cream, Diprosone Ointment, Elocon Cream, Locoid Ointment and LEO 90100 Vehicle

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 25, 2016
Registry last updated
May 9, 2017

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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