SYFdeb9146f84cc419eb710348bbb677a1bRegistry ID: 2024-519946-54-00|RecruitingPhase 4
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interventional
N/A
1 country
1
The treatment effect will be assessed by reduction of HS activity, measured by the IHS4 score at the final follow-up 6 months post-baseline, as the difference between the IHS4 score at baseline (IHS40) and at the six-month follow-up (IHS46). Measurement IHS42 – IHS40= treatment effect. Justification for the use of IHS4: “The IHS4 score is a recognized study scoring system for the treatment effect of HS treatment. It is routinely used for larger HS studies (21,29,30) “
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.
November 29, 2024
Actual (reported)Reduction in IHS4 score
1. Reduction in number of inflammatory nodules, non-inflammatory nodules and draining tunnels. 2. High treatment satisfaction (NRS 0-10). 3. HiSCR50 achieved. 4. Reduction of HiSQOL. 5. DLQI reduction. 6. Pain reduction. 7. Suppuration reduction. 8. Pruritis reduction. 9. Reduction in patient reported disease severity. 10. If the patient would recommend the treatment to others
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
BOTOX, pulver til injektionsvæske, opløsning 100 Allergan-enheder
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
BOTOX, pulver til injektionsvæske, opløsning 100 Allergan-enheder
Named ingredient: Botulinum toxin type a
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Gentofte Hospital
Hellerup, 2900, Denmark
Ditte Marie Saunte
Ditte Marie Saunte
First Submitted
November 29, 2024
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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