Clinical Trial Results:
A double-blind, randomized, vehicle-controlled Proof of Concept (PoC) study, to evaluate the safety, local tolerability, pharmacokinetics and pharmacodynamics of multiple topical administrations of LDE225 (a specific Smoothened inhibitor) on skin basal cell carcinomas in Gorlin syndrome patients followed by an open label, randomized expansion group to test two different strengths of an improved LDE225 formulation for extended treatment durations
Summary
|
|
EudraCT number |
2008-005506-40 |
Trial protocol |
AT |
Global completion date |
19 Aug 2010
|
Paediatric regulatory details
|
|
Is the trial part of an agreed EMA paediatric investigation plan? |
No
|
Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
|
Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
13 Apr 2016
|
First version publication date |
13 Apr 2016
|
Other versions |
|
Summary report(s) |
CLDE225B2203 CT.gov results public |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.