Vasoconstriction Trial With LEO 90100 Aerosol Foam
Vasoconstriction Trial Comparing LEO 90100 With Dermovate Cream, Diprosone Ointment, Elocon Cream, Locoid Ointment and LEO 90100 Vehicle
1 other identifier
interventional
36
1 country
1
Brief Summary
Vasoconstriction study with LEO 90100
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2016
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 22, 2016
CompletedFirst Posted
Study publicly available on registry
November 25, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedMay 9, 2017
May 1, 2017
2 months
November 22, 2016
May 8, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Mean of two visual skin blanching scores for each treatment measured 2 hours after 16 hours application under non-occlusive conditions
18 hours
Study Arms (6)
LEO 90100 aerosol foam
EXPERIMENTALLEO 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.
Dermoval®/Dermovate®
ACTIVE COMPARATORDermoval®/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.
Diprosone®
ACTIVE COMPARATORDiprosone® 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.
Elocon®
ACTIVE COMPARATORElocon® 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.
Locoid®
ACTIVE COMPARATORLocoid® 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.
LEO 90100 foam vehicle
PLACEBO COMPARATORLEO 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LEO Pharmalead
Study Sites (1)
CPCAD
Nice, Cedex, 06202, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 22, 2016
First Posted
November 25, 2016
Study Start
December 1, 2016
Primary Completion
February 1, 2017
Study Completion
February 1, 2017
Last Updated
May 9, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share