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A Vasoconstriction Study With LEO 90100

Information source: LEO Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriasis Vulgaris

Intervention: LEO 90100 Aerosol, foam (Drug); Betamethasone dipropionate in LEO 90100 Aerosol, foam, vehicle (Drug); LEO 90100 Aerosol, foam, vehicle (Drug); Daivobet® ointment (Drug); Dermovate® cream (Drug); Synalar® ointment (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: LEO Pharma

Summary

The purpose of this study is to compare the pharmacodynamic activity of LEO 90100 with Dermovate cream, Dovobet ointment, betamethasone dipropionate in LEO90100 vehicle, Synalar ointment and LEO 90100 vehicle using a human skin blanching test.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Primary outcome: Visual assessment of skin blanching (visual score (VS))

Secondary outcome:

Change from baseline in colorimetric parameter a* (the red/green balance) at each time point

Change from baseline in colorimetric parameter L* (luminance) at each time point (ΔL*)

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Following verbal and written information about the trial, the subject must provide

signed and dated informed consent before any study related activities are carried out.

- Healthy male or female volunteers, 18 to 50 years old, both inclusive

Exclusion Criteria:

- Female subjects who are pregnant or who are breast feeding.

- Abnormal pigmentation of the skin or skin type that could, in any way, confound

interpretation of the study results (skin type V and VI on the Fitzpatrick scale)

Locations and Contacts

CPCAD, Centre de Pharmacologie Clinique Appliquée à la Dermatologie, Nice 06202, France
Additional Information

Starting date: September 2013
Last updated: July 17, 2015

Page last updated: August 23, 2015

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