SYFe1474da61f94414ea0683d8ed8abb0f9Registry ID: 2024-519201-36-00|UnknownPhase 2Results
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interventional
N/A
1 country
1
To evaluate if dantrolene treatment reduce skin area affected.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 28, 2024
Actual (reported)The primary endpoint will be a reduction of skin area affected using the 5-point Physician Global Assessment (PGA) scale (23). A 20 % reduction (1 point) will be considered the minimal clinically important difference.
As the main secondary endpoint, improvement in dermatological quality of life index (DLQI) will be used. A 4 points improvement in DLQI will be considered the minimal clinically important difference (24). We will also examine mood with the Montgomery–Åsberg Depression Rating Scale (MADRS) and treatment satisfaction with the Treatment Satisfaction Questionnaire for Medication (TSQM).
As complementary skin assessment tools we will use the Eczema Area and Severity Index (EASI) scale and Body Surface Area (BSA).
Number of adverse events and adverse reactions, serious and non-serious.
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Formulated product
Dantrium Capsules 25mg
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, HARD
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Dantrium Capsules 25mg
Named ingredient: Dantrolene sodium
View registry recordKarolinska University Hospital
Solna, 171 64, Sweden
Dr Jakob Wikström
First Submitted
October 28, 2024
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