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Vasoconstriction Trial With LEO 90100 Aerosol Foam

Primary Purpose

Psoriasis Vulgaris

Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
LEO 90100 aerosol foam
Dermoval®/Dermovate®
Diprosone
Elocon
Locoid
LEO 90100 foam vehicle
Sponsored by
LEO Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis Vulgaris

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • CPCAD

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

LEO 90100 aerosol foam

Dermoval®/Dermovate®

Diprosone®

Elocon®

Locoid®

LEO 90100 foam vehicle

Arm Description

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 22, 2016
Last Updated
May 8, 2017
Sponsor
LEO Pharma
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1. Study Identification

Unique Protocol Identification Number
NCT02973776
Brief Title
Vasoconstriction Trial With LEO 90100 Aerosol Foam
Official Title
Vasoconstriction Trial Comparing LEO 90100 With Dermovate Cream, Diprosone Ointment, Elocon Cream, Locoid Ointment and LEO 90100 Vehicle
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
December 2016 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LEO Pharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Vasoconstriction study with LEO 90100
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LEO 90100 aerosol foam
Arm Type
Experimental
Arm Description
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.
Arm Title
Dermoval®/Dermovate®
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Diprosone®
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Elocon®
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Locoid®
Arm Type
Active Comparator
Arm Description
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.
Arm Title
LEO 90100 foam vehicle
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
LEO 90100 aerosol foam
Intervention Type
Drug
Intervention Name(s)
Dermoval®/Dermovate®
Intervention Type
Drug
Intervention Name(s)
Diprosone
Intervention Type
Drug
Intervention Name(s)
Elocon
Intervention Type
Drug
Intervention Name(s)
Locoid
Intervention Type
Other
Intervention Name(s)
LEO 90100 foam vehicle
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
CPCAD
City
Nice
State/Province
Cedex
ZIP/Postal Code
06202
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Vasoconstriction Trial With LEO 90100 Aerosol Foam

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