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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01946386
Other study ID # LP0053-69
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 2013
Est. completion date October 2013

Study information

Verified date July 2015
Source LEO Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date October 2013
Est. primary completion date October 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

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

LEO 90100 Aerosol, foam, vehicle

Daivobet® ointment

Dermovate® cream

Synalar® ointment


Locations

Country Name City State
France CPCAD, Centre de Pharmacologie Clinique Appliquée à la Dermatologie Nice

Sponsors (1)

Lead Sponsor Collaborator
LEO Pharma

Country where clinical trial is conducted

France, 

References & 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

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Change from baseline in colorimetric parameter a* (the red/green balance) at each time point Change from baseline in colorimetric parameter. AUC (0-32h) of this change by treatment site will be calculated after subtraction of untreated site change 06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application
Secondary Change from baseline in colorimetric parameter L* (luminance) at each time point (?L*) AUC (0-32h) of this change by treatment site will be calculated after subtraction of untreated site change 06:10, 08:00, 10:00, 12:00, 24:00, 28:00 and 32:00 hours after application
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