Clinical Trial Results:
A 16-week, randomized, multi-center, parallel-group, pimecrolimus-blinded, controlled study (4-week treatment period followed by 12-week observational period) to evaluate the safety of concomitant use of ASM 981 (pimecrolimus) cream 1% (BID) plus topical corticosteroid (BID) for the treatment of severe atopic dermatitis in patients 2 to 17 years of age.
Summary
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EudraCT number |
2005-000839-17 |
Trial protocol |
IT DE |
Global completion date |
24 Jan 2007
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
16 May 2018
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First version publication date |
16 May 2018
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Other versions |
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Summary report(s) |
CASM981C2439 NVS CTR |
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.