Vasoconstriction Trial With LEO 90100 Aerosol Foam

NCT ID: NCT02973776

Last Updated: 2017-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-02-28

Brief Summary

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Vasoconstriction study with LEO 90100

Detailed Description

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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

Conditions

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Psoriasis Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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LEO 90100 aerosol foam

LEO 90100 calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) aerosol foam

Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once.

Group Type EXPERIMENTAL

LEO 90100 aerosol foam

Intervention Type DRUG

Dermoval®/Dermovate®

Intervention Type DRUG

Diprosone

Intervention Type DRUG

Elocon

Intervention Type DRUG

Locoid

Intervention Type DRUG

LEO 90100 foam vehicle

Intervention Type OTHER

Dermoval®/Dermovate®

Dermoval®/Dermovate® (clobetasol propionate 0.05%) cream

Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once.

Group Type ACTIVE_COMPARATOR

LEO 90100 aerosol foam

Intervention Type DRUG

Dermoval®/Dermovate®

Intervention Type DRUG

Diprosone

Intervention Type DRUG

Elocon

Intervention Type DRUG

Locoid

Intervention Type DRUG

LEO 90100 foam vehicle

Intervention Type OTHER

Diprosone®

Diprosone® betamethasone 0.5 mg/g (as dipropionate) ointment

Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once.

Group Type ACTIVE_COMPARATOR

LEO 90100 aerosol foam

Intervention Type DRUG

Dermoval®/Dermovate®

Intervention Type DRUG

Diprosone

Intervention Type DRUG

Elocon

Intervention Type DRUG

Locoid

Intervention Type DRUG

LEO 90100 foam vehicle

Intervention Type OTHER

Elocon®

Elocon® mometasone furoate 0.1% cream

Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once.

Group Type ACTIVE_COMPARATOR

LEO 90100 aerosol foam

Intervention Type DRUG

Dermoval®/Dermovate®

Intervention Type DRUG

Diprosone

Intervention Type DRUG

Elocon

Intervention Type DRUG

Locoid

Intervention Type DRUG

LEO 90100 foam vehicle

Intervention Type OTHER

Locoid®

Locoid® hydrocortisone-17-butyrate 0.1% ointment

Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once.

Group Type ACTIVE_COMPARATOR

LEO 90100 aerosol foam

Intervention Type DRUG

Dermoval®/Dermovate®

Intervention Type DRUG

Diprosone

Intervention Type DRUG

Elocon

Intervention Type DRUG

Locoid

Intervention Type DRUG

LEO 90100 foam vehicle

Intervention Type OTHER

LEO 90100 foam vehicle

LEO 90100 foam vehicle

Each subject has all 6 treatments applied topically at the same time, however, the location on which the treatments are applied is randomised. Subjects will receive approximately 20 μl of each investigational product applied in circles with a diameter of 2.2 cm once.

Group Type PLACEBO_COMPARATOR

LEO 90100 aerosol foam

Intervention Type DRUG

Dermoval®/Dermovate®

Intervention Type DRUG

Diprosone

Intervention Type DRUG

Elocon

Intervention Type DRUG

Locoid

Intervention Type DRUG

LEO 90100 foam vehicle

Intervention Type OTHER

Interventions

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LEO 90100 aerosol foam

Intervention Type DRUG

Dermoval®/Dermovate®

Intervention Type DRUG

Diprosone

Intervention Type DRUG

Elocon

Intervention Type DRUG

Locoid

Intervention Type DRUG

LEO 90100 foam vehicle

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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LEO Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CPCAD

Nice, Cedex, France

Site Status

Countries

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France

Other Identifiers

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LP0053-1276

Identifier Type: -

Identifier Source: org_study_id

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