Vasoconstriction Trial With LEO 90100 Aerosol Foam

LEO Pharma

Status and phase: Completed; Phase 1

Conditions: Psoriasis Vulgaris

Treatments: Drug: Locoid; Other: LEO 90100 foam vehicle; Drug: Dermoval®/Dermovate®; Drug: LEO 90100 aerosol foam; Drug: Diprosone; Drug: Elocon

Study type: Interventional

Funder types: Industry

Identifiers

NCT02973776

LP0053-1276

Details and patient eligibility

About

Vasoconstriction study with LEO 90100

Full 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

Enrollment: 36 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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36 participants in 6 patient groups, including a placebo group

LEO 90100 aerosol foam

Experimental group

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.

Treatment:

Drug: Locoid

Drug: Elocon

Drug: LEO 90100 aerosol foam

Drug: Dermoval®/Dermovate®

Other: LEO 90100 foam vehicle

Drug: Diprosone

Dermoval®/Dermovate®

Active Comparator group

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.

Treatment:

Drug: Locoid

Drug: Elocon

Drug: LEO 90100 aerosol foam

Drug: Dermoval®/Dermovate®

Other: LEO 90100 foam vehicle

Drug: Diprosone

Diprosone®

Active Comparator group

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.

Treatment:

Drug: Locoid

Drug: Elocon

Drug: LEO 90100 aerosol foam

Drug: Dermoval®/Dermovate®

Other: LEO 90100 foam vehicle

Drug: Diprosone

Elocon®

Active Comparator group

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.

Treatment:

Drug: Locoid

Drug: Elocon

Drug: LEO 90100 aerosol foam

Drug: Dermoval®/Dermovate®

Other: LEO 90100 foam vehicle

Drug: Diprosone

Locoid®

Active Comparator group

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.

Treatment:

Drug: Locoid

Drug: Elocon

Drug: LEO 90100 aerosol foam

Drug: Dermoval®/Dermovate®

Other: LEO 90100 foam vehicle

Drug: Diprosone

LEO 90100 foam vehicle

Placebo Comparator group

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.

Treatment:

Drug: Locoid

Drug: Elocon

Drug: LEO 90100 aerosol foam

Drug: Dermoval®/Dermovate®

Other: LEO 90100 foam vehicle

Drug: Diprosone