Clinical trial • Dermatology

CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS for Wrinkles, fine lines

Clinical trial of CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS for Wrinkles, fine lines.

Overview

Trial Therapeutic Area
Dermatology
Trial Disease
Wrinkles, fine lines
Drug Modality
Peptide/protein/enzyme|Other

Key dates

Initial CTIS Submission Date
28-01-2025
First CTIS Authorization Date
29-01-2025

Trial design

Bocouture 100 eenheden poeder voor oplossing voor injectie (active; active substance: CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS) - product information: dose unit U, max daily dose 56 U, max total dose 112 U; Route: SOLUTION FOR INJECTION. Comparator: Placebo to NT201 - matched placebo; Route: SOLUTION FOR INJECTION; max daily dose 56 U, max total dose 112 U (placebo product record).-controlled trial across 1 site in Netherlands.

Comparator
Bocouture 100 eenheden poeder voor oplossing voor injectie (active; active substance: CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS) - product information: dose unit U, max daily dose 56 U, max total dose 112 U; Route: SOLUTION FOR INJECTION. Comparator: Placebo to NT201 - matched placebo; Route: SOLUTION FOR INJECTION; max daily dose 56 U, max total dose 112 U (placebo product record).
Target Sample Size
52

Eligibility

Recruits 52 Vulnerable population not selected; participants aged 18-65 years; informed consent required from each participant (see document 'L1_NL-NL_SIS and ICF 18-65 yr'); no assent/child consent procedures described..

Pregnancy Exclusion
Females who are pregnant, planning to get pregnant during the full duration of the study, or breastfeeding.
Vulnerable Population
Vulnerable population not selected; participants aged 18-65 years; informed consent required from each participant (see document 'L1_NL-NL_SIS and ICF 18-65 yr'); no assent/child consent procedures described.

Inclusion criteria

  • {"criterion_text":"- Males or females, 18 to 65 years of age, inclusive;\n- General good health status;\n- Symmetrical rhytids on both sides of the face, expressed by a Merz Aesthetics Scales score in dynamic ≥ 2 in all treatment areas;\n- Client overall satisfaction score ≥ 2 and ≤ 8 based on the eVAS Satisfaction Scale (0- 10);\n- Able to participate and willing to give informed consent and comply with the study restrictions."}

Exclusion criteria

  • {"criterion_text":"- Clients with known allergies or sensitivity to the drug or any components of the study medication;\n- Clients with body dysmorphic disorder or related diagnosis in the DSM-V.\n- Use of any agent that impedes the neuromuscular transmission, or other neuromuscular diseases that could amplify the effects of botulinum toxin type A treatment (e.g. myasthenia gravis, excessive weakness, Eaton-Lambert syndrome, or atrophy of target muscles);\n- Previous exposure to botulinum toxin < 6 months before the first treatment;\n- Has ever received a permanent filler in the upper face, or has received a temporary filler in the upper face in the last two years;\n- Presence of an infection, or any type of skin disease, in the treatment area;\n- Presence or history of a malignancy like melanoma in the treated area;\n- Grade 4 lines in one or more of the treatment areas expressed by the Merz Aesthetic Scales;\n- Marked asymmetry of the crow's feet by 1 point on the Merz Aesthetic Scales;\n- Females who are pregnant, planning to get pregnant during the full duration of the study, or breastfeeding."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Difference between the intervention and control group in change from baseline eVAS Satisfaction Scale - Overall Satisfaction Score at Visit 6 (follow-up).","definition_or_measurement_approach":"Change from baseline to Visit 6 (follow-up); measured using the eVAS Satisfaction Scale - Overall Satisfaction Score as assessed by the client (follow-up 2 months after the last treatment)."}

Secondary endpoints

  • {"endpoint_text":"- Adverse events.","definition_or_measurement_approach":"Safety and tolerability after multiple doses of NT201 as determined by adverse event (AE) reporting."}

Recruitment

Planned Sample Size
52
Recruitment Window Months
72
Consent Approach
Informed consent required from each participant (participants must be able and willing to give informed consent). Consent documents: 'L1_NL-NL_SIS and ICF 18-65 yr' (subject information sheet and ICF for ages 18-65) in Dutch (NL-NL). No assent or minor consent described; participants are adults (18-65).

Geography

Total Number Of Sites
1
Total Number Of Participants
52

Netherlands

Earliest CTIS Part Ii Submission Date
28-01-2025
Latest Decision Or Authorization Date
10-06-2025
Processing Time Days
133
Number Of Sites
1
Number Of Participants
52

Sites

Site Name
Falck clinic
Department Name
UMA institute
Principal Investigator Name
Jani van Loghem
Principal Investigator Email
jani@uma-institute.com
Contact Person Name
Jani van Loghem
Contact Person Email
jani@uma-institute.com
Number Of Participants
52

Sponsor

Primary sponsor

Full Name
Falck clinic
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Netherlands

Third parties

  • {"country":"Germany","full_name":"Merz pharma (Germany)","duties_or_roles":"Source of monetary support","organisation_type":""}

Investigational products

Investigational Product Name
Bocouture 100 eenheden poeder voor oplossing voor injectie
Active Substance
CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS
Modality
Peptide/protein/enzyme
Routes Of Administration
SOLUTION FOR INJECTION
Route
SOLUTION FOR INJECTION
Authorisation Status
Authorised (marketing authorisation RVG 117448 in NL)
Maximum Dose
112 U (max total); max daily 56 U
Investigational Product Name
Placebo to NT201
Modality
Other
Routes Of Administration
SOLUTION FOR INJECTION
Route
SOLUTION FOR INJECTION
Maximum Dose
112 U (max total); max daily 56 U

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