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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01837576
Other study ID # LP0076-1016
Secondary ID
Status Completed
Phase Phase 1
First received April 18, 2013
Last updated July 22, 2013
Start date April 2013
Est. completion date June 2013

Study information

Verified date April 2013
Source LEO Pharma
Contact n/a
Is FDA regulated No
Health authority France: ANSM French Health Products Safety Agency
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the antipsoriatic effect of 5 different combinations of calcipotriol plus betamethasone dipropionate in Daivobet® gel vehicle in compared to Daivobet® gel in order to explore/find other safe and effective combination of the two components.


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Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator)


Related Conditions & MeSH terms


Intervention

Drug:
Calcipotriol plus BDP gel in different doses
Topical , Once daily, 3 weeks

Locations

Country Name City State
France Centre de harmacologie Clinique Appliquée à la Dermatologie (CPCAD) Nice Nice Cedex 3

Sponsors (1)

Lead Sponsor Collaborator
LEO Pharma

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary The absolute change in Total Clinical Score (TCS) of clinical symptoms (sum of erythema, scaling and infiltration) 3 weeks No
Secondary Absolute change in single clinical symptom score: erythema, scaling, infiltration at end of treatment and individual visits compared to baseline. 3 weeks No
Secondary Absolute change in Total Clinical Score (TCS) at individual visits compared to baseline 3 weeks No
Secondary The absolute change in total skin thickness and echopoor band thickness at end of treatment compared to baseline. 3 weeks No
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