A Vasoconstriction Study With LEO 90100
1 other identifier
interventional
35
1 country
1
Brief 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.
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 Sep 2013
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
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 11, 2013
CompletedFirst Posted
Study publicly available on registry
September 19, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedFebruary 24, 2025
July 1, 2015
1 month
September 11, 2013
February 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Visual assessment of skin blanching (visual score (VS))
Visual Assessment of Skin Blanching on scores 0 to 4
06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application
Secondary Outcomes (2)
Change from baseline in colorimetric parameter a* (the red/green balance) at each time point
06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application
Change from baseline in colorimetric parameter L* (luminance) at each time point (ΔL*)
06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application
Study Arms (1)
LEO 90100
EXPERIMENTALInterventions
The products will be applied on 6 test sites (according to random assignment to specific test sites predetermined on their anterior face of forearms) for 6 hours
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LEO Pharmalead
Study Sites (1)
CPCAD, Centre de Pharmacologie Clinique Appliquée à la Dermatologie
Nice, 06202, France
Related Publications (1)
Queille-Roussel C, Bang B, Clonier F, Lacour JP. Phase I evaluation of the vasoconstrictor potential of an innovative fixed combination calcipotriene plus betamethasone dipropionate aerosol foam versus other corticosteroid psoriasis treatments. J Am Acad Dermatol. 2015:72 Suppl 1;AB243 (P915).
RESULT
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Medical Expert
LEO Pharma
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
September 11, 2013
First Posted
September 19, 2013
Study Start
September 1, 2013
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
February 24, 2025
Record last verified: 2015-07
Data Sharing
- IPD Sharing
- Will not share