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Trial record 65 of 90 for:    cream | "Psoriasis"

Vasoconstriction Trial With LEO 90100 Aerosol Foam

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ClinicalTrials.gov Identifier: NCT02973776
Recruitment Status : Completed
First Posted : November 25, 2016
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Brief Summary:
Vasoconstriction study with LEO 90100

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Drug: LEO 90100 aerosol foam Drug: Dermoval®/Dermovate® Drug: Diprosone Drug: Elocon Drug: Locoid Other: LEO 90100 foam vehicle Phase 1

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  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Vasoconstriction Trial Comparing LEO 90100 With Dermovate Cream, Diprosone Ointment, Elocon Cream, Locoid Ointment and LEO 90100 Vehicle
Study Start Date : December 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

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



Primary Outcome Measures :
  1. Mean of two visual skin blanching scores for each treatment measured 2 hours after 16 hours application under non-occlusive conditions [ Time Frame: 18 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02973776


Locations
France
CPCAD
Nice, Cedex, France, 06202
Sponsors and Collaborators
LEO Pharma

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT02973776     History of Changes
Other Study ID Numbers: LP0053-1276
First Posted: November 25, 2016    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Hydrocortisone-17-butyrate
Mometasone Furoate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Hydrocortisone
Betamethasone
Betamethasone Valerate
Clobetasol
Betamethasone sodium phosphate
Dermatologic Agents
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Anti-Allergic Agents