Overview
Sponsor-declared trial summary
Wrinkles, fine lines
To evaluate the difference in treatment response between the intervention group and control group, defined as the change from baseline to at follow-up (2 months after the last treatment) on the eVAS Satisfaction Score - Overall Satisfaction Score as assessed by the client.
Key facts
- Sponsor
- Falck clinic
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Biological Phenomena [G16], Phenomena and Processes [G] - Physical Phenomena [G01], Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 12 Jan 2023 → ongoing
- Decision date (initial)
- 2025-01-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Merz pharma (Germany)
External identifiers
- EU CT number
- 2025-520915-14-00
- EudraCT number
- 2017-004278-32
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To evaluate the difference in treatment response between the intervention group and control group, defined as the change from baseline to at follow-up (2 months after the last treatment) on the eVAS Satisfaction Score - Overall Satisfaction Score as assessed by the client.
Secondary objectives 1
- To evaluate the safety and tolerability after multiple doses of NT201 as determined by AE reporting.
Conditions and MedDRA coding
Wrinkles, fine lines
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10052609 | Glabellar frown lines | 10040785 |
| 21.1 | LLT | 10052610 | Frown lines | 10040785 |
| 20.0 | LLT | 10071433 | Forehead lift | 10042613 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Males or females, 18 to 65 years of age, inclusive;
- General good health status;
- Symmetrical rhytids on both sides of the face, expressed by a Merz Aesthetics Scales score in dynamic ≥ 2 in all treatment areas;
- Client overall satisfaction score ≥ 2 and ≤ 8 based on the eVAS Satisfaction Scale (0- 10);
- Able to participate and willing to give informed consent and comply with the study restrictions.
Exclusion criteria 10
- Clients with known allergies or sensitivity to the drug or any components of the study medication;
- 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);
- Previous exposure to botulinum toxin < 6 months before the first treatment;
- 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;
- Presence of an infection, or any type of skin disease, in the treatment area;
- Presence or history of a malignancy like melanoma in the treated area;
- Grade 4 lines in one or more of the treatment areas expressed by the Merz Aesthetic Scales;
- Marked asymmetry of the crow's feet by 1 point on the Merz Aesthetic Scales;
- Females who are pregnant, planning to get pregnant during the full duration of the study, or breastfeeding.
- Clients with body dysmorphic disorder or related diagnosis in the DSM-V.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Difference between the intervention and control group in change from baseline eVAS Satisfaction Scale - Overall Satisfaction Score at Visit 6 (follow-up).
Secondary endpoints 1
- Adverse events.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Bocouture 100 eenheden poeder voor oplossing voor injectie
PRD4651295 · Product
- Active substance
- Clostridium Botulinum Neurotoxin Type a (150KD), Free of Complexing Proteins
- Substance synonyms
- IncobotulinumtoxinA, NT 201, Botulinum toxin type A (150 kD), free from complexing proteins
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 56 U unit(s)
- Max total dose
- 112 U unit(s)
- Max treatment duration
- 8 Month(s)
- Authorisation status
- Authorised
- ATC code
- M03AX01 — BOTULINUM TOXIN
- Marketing authorisation
- RVG 117448
- MA holder
- MERZ PHARMACEUTICALS GMBH
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 56 U unit(s)
- Max total dose
- 112 U unit(s)
- Max treatment duration
- 8 Month(s)
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Falck clinic
- Sponsor organisation
- Falck clinic
- Address
- Falckstraat 51
- City
- Amsterdam
- Postcode
- 1017 VV
- Country
- Netherlands
Scientific contact point
- Organisation
- Falck clinic
- Contact name
- Aina Cervera i Barea
Public contact point
- Organisation
- Falck clinic
- Contact name
- Aina Cervera i Barea
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruiting | 52 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2023-01-12 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 12 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-520915-14-00 | 8 |
| Protocol (for publication) | D1_SoC in protocol 2025-520915-14-00 | 2 |
| Protocol (for publication) | D4a_NL-NL_Pacient facing document_VAS Satisfaction Scale | 1 |
| Protocol (for publication) | D4b_NL-EN_Pacient facing document_Merz Aesthetic Scale | 1 |
| Protocol (for publication) | D4c_NL-NL_Pacient facing document_Global Aesthetic Improvement Scale | 1 |
| Protocol (for publication) | D4d_NL-EN_Pacient facing document_BeautyQol UK | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 3 |
| Recruitment arrangements (for publication) | K2_NL-NL_Recruitment material_advertisements | 3 |
| Subject information and informed consent form (for publication) | L1_NL-NL_SIS and ICF 18-65 yr | 5 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Bocouture | 1 |
| Synopsis of the protocol (for publication) | D1_NL-EN_Protocol synopsis_2025-520915-14-00 | 1 |
| Synopsis of the protocol (for publication) | D1_NL-NL_Protocol synopsis_2025-520915-14-00 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-28 | Netherlands | Acceptable 2025-01-29
|
2025-01-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-14 | Netherlands | Acceptable 2025-06-10
|
2025-06-10 |