A Vasoconstriction Study With LEO 90100

LEO Pharma

Status and phase: Completed; Phase 1

Conditions: Psoriasis Vulgaris

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01946386

LP0053-69

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

---

35 participants in 1 patient group

LEO 90100

Experimental group

Treatment:

Drug: Dermovate® cream

Drug: LEO 90100 Aerosol, foam, vehicle

Drug: LEO 90100 Aerosol, foam

Drug: Synalar® ointment

Drug: Daivobet® ointment

Drug: Betamethasone dipropionate in LEO 90100 Aerosol, foam, vehicle