Clinical trial • Not applicable • Dermatology|Immunology
BOTULINUM TOXIN TYPE A for Hidradenitis Suppurativa
Not applicable trial of BOTULINUM TOXIN TYPE A for Hidradenitis Suppurativa.
Overview
- Trial Therapeutic Area
- Dermatology|Immunology
- Trial Disease
- Hidradenitis Suppurativa
- Trial Stage
- Not applicable
- Drug Modality
- Peptide/protein/enzyme|Small molecule
Key dates
- Initial CTIS Submission Date
- 29-11-2024
- First CTIS Authorization Date
- 25-02-2025
Trial design
Randomised, placebo: natriumklorid isotonisk "sad", solution for injection (isotonic sodium chloride). test products: botox (botox, pulver til injektionsvæske, opløsning 100 allergan-enheder, botulinum toxin type a), xeomin (xeomin 100 units powder for solution for injection, incobotulinumtoxina), dysport (dysport, powder for solution for injection 300 units, abobotulinumtoxina). specific injection dosing/schedule per treated area as per protocol/smpc; no detailed dosing schedule specified in ctis json.-controlled Not applicable trial across 1 site in Denmark.
- Randomised
- Yes
- Comparator
- Placebo: Natriumklorid isotonisk "SAD", solution for injection (isotonic sodium chloride). Test products: BOTOX (BOTOX, pulver til injektionsvæske, opløsning 100 Allergan-enheder, botulinum toxin type A), XEOMIN (XEOMIN 100 units powder for solution for injection, incobotulinumtoxinA), Dysport (Dysport, powder for solution for injection 300 units, abobotulinumtoxinA). Specific injection dosing/schedule per treated area as per protocol/SmPC; no detailed dosing schedule specified in CTIS JSON.
- Target Sample Size
- 20
- Trial Duration For Participant
- 183
Eligibility
Recruits 20 No vulnerable populations selected. Participants must be >18 years old and cognitively intact to complete questionnaires; those unable to give informed consent are excluded. Informed consent is required from each participant..
- Pregnancy Exclusion
- Pregnancy
- Vulnerable Population
- No vulnerable populations selected. Participants must be >18 years old and cognitively intact to complete questionnaires; those unable to give informed consent are excluded. Informed consent is required from each participant.
Inclusion criteria
- {"criterion_text":"- Bilaterally affected areas on both sides of the body with the same degree of severity according to the Hurley stage\n- HS-patient at Gentofte Hospital\n- Signed informed consent before inclusion\n- Patient must have hidradenitis suppurativa diagnosis verified by a dermatologist\n- Patients must be cognitively intact enough to independently answer questions in the questionnaires\n- > 18 years old"}
Exclusion criteria
- {"criterion_text":"- Myasthenia gravis\n- Eaton-Lamberts syndrom\n- Other neuromuscular disorders\n- Sensitivity/allergy over the ingredients\n- Pregnancy\n- Breastfeeding\n- Wish or plan to become pregnant\n- Emergency medical treatment for HS, such as intralesional triamcinolone injections in the treated areas\n- Emergency surgical treatment of HS in the treated areas\n- Comprised respiratory function\n- Patients taking one of following medications: aminoglycosides, anticholinergic drugs and muscle relaxants\n- Patient unable to give informed consent"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Reduction in IHS4 score","definition_or_measurement_approach":"IHS4 score measured as the difference between baseline (IHS4_0) and six-month follow-up (IHS4_6); primary assessment at final follow-up 6 months post-baseline. IHS4 categories: Mild ≤3, Moderate 4-10, Severe ≥11."}
Secondary endpoints
- {"endpoint_text":"- 1. Reduction in number of inflammatory nodules, non-inflammatory nodules and draining tunnels.\n- 2. High treatment satisfaction (NRS 0-10).\n- 3. HiSCR50 achieved.\n- 4. Reduction of HiSQOL.\n- 5. DLQI reduction.\n- 6. Pain reduction.\n- 7. Suppuration reduction.\n- 8. Pruritis reduction.\n- 9. Reduction in patient reported disease severity.\n- 10. If the patient would recommend the treatment to others","definition_or_measurement_approach":"Assessments at baseline (t=0), at 3 months (t=3) and at 6 months follow-up (t=6). Nodule/tunnel counts recorded; treatment satisfaction by NRS 0-10; HiSCR50 achievement recorded; HiSQOL scored 0-60 (items 0-4); DLQI scored 0-30 (MCID ≥4-unit decrease); Pain, Suppuration, Pruritus and patient-reported severity measured by NRS 0-10 (MCID for pain/pruritus ≥30% and ≥1 point)."}
Recruitment
- Planned Sample Size
- 20
- Recruitment Window Months
- 36
- Consent Approach
- Signed informed consent required before inclusion from each participant (>18 years). Consent documents available (document titles: 'Subject information', 'Samtykkeerklring habile patienter'); consent by participant only (no assent for minors as only adults included). Documents include Danish-language materials.
Methods
- Recruit from HS patients at Gentofte Hospital (target: adult patients with Hidradenitis Suppurativa treated/seen at Gentofte Hospital in Denmark).
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 20
Denmark
- Earliest CTIS Part Ii Submission Date
- 06-02-2025
- Latest Decision Or Authorization Date
- 25-02-2025
- Processing Time Days
- 19
- Number Of Sites
- 1
- Number Of Participants
- 20
Sites
- Site Name
- Gentofte Hospital
- Department Name
- Department of Dermatology and Allergy
- Principal Investigator Name
- Ditte Marie Saunte
- Principal Investigator Email
- ditte.marie.saunte@regionh.dk
- Contact Person Name
- Ditte Marie Saunte
- Contact Person Email
- ditte.marie.saunte@regionh.dk
- Number Of Participants
- 20
Sponsor
Primary sponsor
- Full Name
- Gentofte Hospital
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Denmark
Third parties
- {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"Sponsor duty code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}
Co-sponsors
- Frederiksberg Hospital
Investigational products
- Investigational Product Name
- BOTOX, pulver til injektionsvæske, opløsning 100 Allergan-enheder
- Active Substance
- BOTULINUM TOXIN TYPE A
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Injection
- Route
- Injection
- Authorisation Status
- Marketing authorisation present (marketingAuthNumber: 31350)
- Maximum Dose
- 400 U unit(s)
- Investigational Product Name
- XEOMIN 100 units powder for solution for injection
- Active Substance
- CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Injection
- Route
- Injection
- Authorisation Status
- Marketing authorisation present (mrpNumber: DE/H/0722/001; marketingAuthNumber: MA025/00701)
- Maximum Dose
- 250 U unit(s)
- Investigational Product Name
- Dysport, pulver til injektionsvæske, opløsning 300 enheder
- Active Substance
- BOTULINUM TOXIN TYPE A - HAEMAGGLUTININ COMPLEX
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- Injection
- Route
- Injection
- Authorisation Status
- Marketing authorisation present (marketingAuthNumber: 46570)
- Maximum Dose
- 1000 U unit(s)
- Investigational Product Name
- Natriumklorid isotonisk "SAD", injektionsvæske, opløsning
- Active Substance
- SODIUM CHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- Injection
- Route
- Injection
- Authorisation Status
- Marketing authorisation present (marketingAuthNumber: 16404)
- Maximum Dose
- 0 U unit(s)
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