Vasoconstriction Trial With LEO 90100 Aerosol Foam

Psoriasis Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02973776
• Other study ID #: LP0053-1276
• Status: Completed
• Phase: Phase 1
• First received: November 22, 2016
• Last updated: May 8, 2017
• Start date: December 2016
• Est. completion date: February 2017

Study information

• Verified date: May 2017
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Vasoconstriction study with LEO 90100

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• LEO 90100 aerosol foam

• Dermoval®/Dermovate®

• Diprosone

• Elocon

• Locoid

Other:
• LEO 90100 foam vehicle

Locations

Country	Name	City	State
France	CPCAD	Nice	Cedex

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean of two visual skin blanching scores for each treatment measured 2 hours after 16 hours application under non-occlusive conditions		18 hours