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Taking peoplePhase 4

Botox Treatment for Patients with Hidradenitis Suppurativa: A Within-Person, Randomized, Double-blind, Controlled Study

Key facts

Who runs it
Gentofte Hospital
Where
Denmark1 site in 1 countryChoose a country to see its sites
Status
Recruiting
Phase
Phase 4
People taking part
20 people, planned
Started
1 Apr 2025
Expected to end
1 Jan 2029
Type of study
Interventional
Record updated
9 June 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 2 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

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Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Record updated
9 June 2026