Vasoconstriction Trial With LEO 90100 Aerosol Foam

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

Vasoconstriction study with LEO 90100

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Drug: LEO 90100 aerosol foam; Drug: Dermoval®/Dermovate®; Drug: Diprosone; Drug: Elocon; Drug: Locoid; Other: LEO 90100 foam vehicle

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

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• France
  • Cedex
    • Nice, Cedex, France, 06202
      • CPCAD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: LEO 90100 aerosol foam; Drug: Dermoval®/Dermovate®; Drug: Diprosone; Drug: Elocon; Drug: Locoid; Other: LEO 90100 foam vehicle
Active Comparator: 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.	Drug: LEO 90100 aerosol foam; Drug: Dermoval®/Dermovate®; Drug: Diprosone; Drug: Elocon; Drug: Locoid; Other: LEO 90100 foam vehicle
Active Comparator: 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.	Drug: LEO 90100 aerosol foam; Drug: Dermoval®/Dermovate®; Drug: Diprosone; Drug: Elocon; Drug: Locoid; Other: LEO 90100 foam vehicle
Active Comparator: 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.	Drug: LEO 90100 aerosol foam; Drug: Dermoval®/Dermovate®; Drug: Diprosone; Drug: Elocon; Drug: Locoid; Other: LEO 90100 foam vehicle
Active Comparator: 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.	Drug: LEO 90100 aerosol foam; Drug: Dermoval®/Dermovate®; Drug: Diprosone; Drug: Elocon; Drug: Locoid; Other: LEO 90100 foam vehicle
Placebo Comparator: 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.	Drug: LEO 90100 aerosol foam; Drug: Dermoval®/Dermovate®; Drug: Diprosone; Drug: Elocon; Drug: Locoid; Other: LEO 90100 foam vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean of two visual skin blanching scores for each treatment measured 2 hours after 16 hours application under non-occlusive conditions	18 hours

Collaborators and Investigators

• Sponsor: LEO Pharma

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): February 1, 2017
• Study Completion (Actual): February 1, 2017

Study Registration Dates

• First Submitted: November 22, 2016
• First Submitted That Met QC Criteria: November 22, 2016
• First Posted (Estimate): November 25, 2016

Study Record Updates

• Last Update Posted (Actual): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Betamethasone-17,21-dipropionate; Clobetasol
• Other Study ID Numbers: LP0053-1276

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No