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Botox Treatment for Patients with Hidradenitis Suppurativa: A Within-Person, Randomized, Double-blind, Controlled Study
EU CTIS ID: 2024-519946-54-00
What this study is testing
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) “ 1. The primary objective: IHS4 score: Mild HS: ≤3 points Moderate HS: 4-10 points Severe HS: ≥11 points
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • Bilaterally affected areas on both sides of the body with the same degree of severity according to the Hurley stage • HS-patient at Gentofte Hospital • Signed informed consent before inclusion • Patient must have hidradenitis suppurativa diagnosis verified by a dermatologist • Patients must be cognitively intact enough to independently answer questions in the questionnaires • > 18 years old
You likely can't join if
- • Myasthenia gravis • Eaton-Lamberts syndrom • Other neuromuscular disorders • Sensitivity/allergy over the ingredients • Pregnancy • Breastfeeding • Wish or plan to become pregnant • Emergency medical treatment for HS, such as intralesional triamcinolone injections in the treated areas • Emergency surgical treatment of HS in the treated areas • Comprised respiratory function • Patients taking one of following medications: aminoglycosides, anticholinergic drugs and muscle relaxants • Patient unable to give informed consent
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.