Clinical trial • Phase III • Other

Clostridium botulinum neurotoxin type A (150kD), free of complexing proteins (incobotulinumtoxinA) for Platysma prominence

Phase III trial of Clostridium botulinum neurotoxin type A (150kD), free of complexing proteins (incobotulinumtoxinA) for Platysma prominence.

Overview

Trial Therapeutic Area
Other
Trial Disease
Platysma prominence
Trial Stage
Phase III
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
02-06-2025
First CTIS Authorization Date
15-09-2025

Trial design

Randomised, open-label, active: nt 201 (bocouture; active substance: clostridium botulinum neurotoxin type a / incobotulinumtoxina), intramuscular solution for infusion; product information indicates dose unit u (unit(s)), maxdailydoseamount 96 u, maxtotaldoseamount 192 u. comparator: placebo excipients (sucrose and human serum albumin) reconstituted with sterile saline; placebo vials identical in appearance to active product vials. randomised, parallel-group, double-blind main period comparing nt 201 vs placebo.-controlled Phase III trial across 30 sites in Poland, Germany, Spain and others.

Randomised
Yes
Open Label
Yes
Comparator
Active: NT 201 (Bocouture; active substance: Clostridium botulinum neurotoxin type A / incobotulinumtoxinA), intramuscular solution for infusion; product information indicates dose unit U (unit(s)), maxDailyDoseAmount 96 U, maxTotalDoseAmount 192 U. Comparator: Placebo excipients (sucrose and human serum albumin) reconstituted with sterile saline; placebo vials identical in appearance to active product vials. Randomised, parallel-group, double-blind main period comparing NT 201 vs placebo.
Target Sample Size
300

Eligibility

Recruits 300 The CTIS record indicates isVulnerablePopulationSelected = true. Subject information and informed consent forms (L1 SIS-ICF) are provided (languages: German, Polish, Spanish, French). Pregnancy follow-up and newborn child health data collection forms are present in the documents (notably for France). Consent is obtained via the provided L1 SIS-ICF forms from the participant (adult participants; minimum age 18). No separate assent procedures for minors are described..

Pregnancy Exclusion
5. For female participants only: A participant is eligible to participate if not pregnant or breastfeeding, and one of the following conditions applies: • Is of non-childbearing potential as defined in the protocol. OR • Is of childbearing potential (CBP) and using an acceptable contraceptive method as described in the protocol.
Vulnerable Population
The CTIS record indicates isVulnerablePopulationSelected = true. Subject information and informed consent forms (L1 SIS-ICF) are provided (languages: German, Polish, Spanish, French). Pregnancy follow-up and newborn child health data collection forms are present in the documents (notably for France). Consent is obtained via the provided L1 SIS-ICF forms from the participant (adult participants; minimum age 18). No separate assent procedures for minors are described.

Inclusion criteria

  • {"criterion_text":"- 1. Is male or female between ≥ 18 and ≤ 65 years old at the time of signing the informed consent."}
  • {"criterion_text":"- 2. Presence of four (medial and lateral, left and right) platysmal bands."}
  • {"criterion_text":"- 3. Has a score of Grade 3 (‘moderate’) or Grade 4 (‘severe’) on the MAPS-D at maximum contraction, as assessed by the investigator and participant (the ratings of the investigator and participant do not have to coincide)."}
  • {"criterion_text":"- 4. Has a response of ‘agree’ or ‘strongly agree’ to Platysma PRO Item #1 (“I am bothered by the appearance of my neck”) AND attain a total score of ≥ 16 for platysma PRO."}
  • {"criterion_text":"- 5. For female participants only: A participant is eligible to participate if not pregnant or breastfeeding, and one of the following conditions applies: • Is of non-childbearing potential as defined in the protocol. OR • Is of childbearing potential (CBP) and using an acceptable contraceptive method as described in the protocol."}

Exclusion criteria

  • {"criterion_text":"- 1. Known hypersensitivity or history of allergic reaction to BoNT of any serotype or any of their formulation ingredients."}
  • {"criterion_text":"- 2. Any medical condition that may put the participant at increased risk with exposure to botulinum toxin of any serotype, including myasthenia gravis, Lambert-Eaton-Syndrome, amyotrophic lateral sclerosis, or any other disorders that might interfere with neuromuscular function."}
  • {"criterion_text":"- 3. Any serious disease or disorder that could, in the judgment of the investigator, interfere with the safe completion of treatment according to this protocol or with study outcome assessments, or compromise participant safety."}
  • {"criterion_text":"- 4. BoNT treatment in the face, jawline, or neck within the last seven months prior to study treatment."}
  • {"criterion_text":"- 5. History of lower face surgery, neck or chest surgery, aesthetic procedures, and orthodontic procedures in the 12 months prior to study treatment, or any other procedures which in the investigator’s judgment would interfere with study evaluations."}
  • {"criterion_text":"- 6. Previous use of any permanent or semi-permanent, calcium hydroxylapatite, facial tissue augmentation therapy, lifting sutures, permanent implants, or autologous fat to the lower face, neck, or chest within 12 months prior to study treatment."}
  • {"criterion_text":"- 7. Previous use of any hyaluronic acid-based or collagen-based biodegradable facial tissue augmentation therapy to the lower face, neck, or chest within 12 months prior to study treatment."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Composite achievement of Grade 1 (‘none to minimal’) or Grade 2 (‘mild’) AND at least a 2-grade improvement from baseline based on both the investigator’s assessment and participant’s self-assessment using the MAPS-D at Visit 4 (V4; Main Period [MP] Week 2).","definition_or_measurement_approach":"Measured by MAPS-D (Merz Aesthetics platysmal band scale) at Visit 4 (Main Period Week 2); composite requires both investigator and participant assessments to meet Grade 1 or 2 and at least a 2-grade improvement from baseline."}

Secondary endpoints

  • {"endpoint_text":"- • Achievement of Grade 1 (‘none to minimal’) or Grade 2 (‘mild’) AND at least 2-grade improvement from baseline based on the investigator’s assessment using MAPS-D at V4.","definition_or_measurement_approach":"Investigator assessment using MAPS-D at Visit 4 (V4); requires Grade 1 or 2 and ≥2-grade improvement from baseline."}
  • {"endpoint_text":"- • Achievement of Grade 1 (‘none to minimal’) or Grade 2 (‘mild’) AND at least a 2-grade improvement from baseline based on the participant’s self-assessment using MAPS-D at V4.","definition_or_measurement_approach":"Participant self-assessment using MAPS-D at Visit 4 (V4); requires Grade 1 or 2 and ≥2-grade improvement from baseline."}
  • {"endpoint_text":"- • Achievement of at least a +1 (‘somewhat satisfied’) score using the participant’s satisfaction questionnaire at V4.","definition_or_measurement_approach":"Participant satisfaction questionnaire score at Visit 4 (V4); endpoint defined as ≥ +1 (somewhat satisfied)."}

Recruitment

Planned Sample Size
300
Recruitment Window Months
23
Consent Approach
Informed consent obtained using L1 SIS-ICF subject information and informed consent forms (available in German, Polish, Spanish, French). Separate optional-photo consent forms and pregnancy follow-up consent forms are provided (language-specific L1 documents). Consent is provided by the participant (adults ≥18).

Methods

  • Recruitment procedure documents (K1) provided per country (e.g. K1_DE_Recruitment Procedure for Germany, K1_PL_Recruitment Procedure for Poland, K1_ES_Recruitment Procedure for Spain, K1_FR_Recruitment Procedure bilingual for France).
  • Advertising and recruitment materials (K2) / advertisement brochures in local languages for Germany, Poland, Spain and Poland (K2_DE, K2_PL, K2_ES, K2_PL versions) — indicates use of local-language advertising brochures and advertisement materials targeted at potential participants in each country.

Geography

Total Number Of Sites
30
Total Number Of Participants
300

Poland

Earliest CTIS Part Ii Submission Date
14-08-2025
Latest Decision Or Authorization Date
13-11-2025
Processing Time Days
91
Number Of Sites
13
Number Of Participants
120

Sites

Site Name
Royalderm Agnieszka Nawrocka
Department Name
-
Contact Person Name
Witold Owczarek
Contact Person Email
witold.owczarek@dermedicus.pl
Site Name
Dermoklinika Centrum Medyczne s.c. M. Kierstan. J. Narbutt , A. Lesiak
Department Name
-
Contact Person Name
Dorota Sobolewska-Sztychny
Site Name
Dorota Bystrzanowska “High-Med”. Przychodnia Specjalistyczna
Department Name
-
Contact Person Name
Dorota Bystrzanowska
Site Name
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
Department Name
-
Contact Person Name
Magdalena Boczarska-Jedynak
Site Name
Dermedic Jacek Zdybski
Department Name
-
Contact Person Name
Jacek Zdybski
Contact Person Email
klinikazdybski@gmail.com
Site Name
Dermedic Iwona Zdybska
Department Name
-
Contact Person Name
Beata Polkowska-Pruszyńska
Contact Person Email
recepcja@zdybski.pl
Site Name
Synexus Polska Sp. z o.o.
Department Name
Oddział w Gdyni
Contact Person Name
Agnieszka Cegielska
Contact Person Email
ewa.czwarnog@globalaes.com
Site Name
NZOZ Specjalistyczny Ośrodek Dermatologiczny DERMAL Adam Wroński
Department Name
-
Contact Person Name
Adam Wroński
Contact Person Email
bk@dermal.pl
Site Name
Klinika Ambroziak Sp. z o.o.
Department Name
Klinika Ambroziak Dermatologia
Contact Person Name
Monika Kałowska
Contact Person Email
michal@klinikaambroziak.pl
Site Name
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno-Badawczy Marek Brzewski, Paweł Brzewski S.C.
Department Name
-
Contact Person Name
Paweł Brzewski
Contact Person Email
brzewski@sgd-polska.com
Site Name
Trialmed Sp. z o.o.
Department Name
Trialmed CRS Warszawa
Contact Person Name
Ewa Ring
Contact Person Email
piotr.pokojowczyk@wp.pl
Site Name
Klinika Osipowicz & Turkowski Sp. z o.o.
Department Name
-
Contact Person Name
Katarzyna Osipowicz
Contact Person Email
badaniaklinicze@klinikaotco.pl
Site Name
Clinical Research Group Sp. z o.o.
Department Name
-
Contact Person Name
Kamila Padlewska
Contact Person Email
info@crg-clinical.pl

Germany

Earliest CTIS Part Ii Submission Date
14-08-2025
Latest Decision Or Authorization Date
05-02-2026
Processing Time Days
175
Number Of Sites
11
Number Of Participants
120

Sites

Site Name
CentroDerm GmbH
Contact Person Name
Thomas Dirschka
Contact Person Email
t.dirschka@centroderm.de
Site Name
Hamburg University
Department Name
Department of Chemistry
Contact Person Name
Martina Kerscher
Contact Person Email
martina.kerscher@unihamburg.de
Site Name
Fachaerztliche Gemeinschaftspraxis fuer Dermatologie Und Venerologie Allergologie Umweltmedizin Lasermedizin GbR
Contact Person Name
Michael Sebastian
Contact Person Email
m.sebastian@derma-mahlow.de
Site Name
Privatpraxis Dr. Hilton & Partner
Contact Person Name
Rodrigo Marques Da Mota
Contact Person Email
r.mota@dr-hilton.de
Site Name
Medicorium GmbH
Contact Person Name
Daniela Greiner-Krüger
Contact Person Email
studienzentrum@medicorium.de
Site Name
Dr. Niesmann And Dr. Othlinghaus GbR
Contact Person Name
Johannes Niesmann
Site Name
Privatpraxis für Dermatologie und Ästhetik Dr. Tatjana Pavicic
Contact Person Name
Tatjana Pavicic
Contact Person Email
tpavicic@dr-pavicic.de
Site Name
Derma Science GmbH
Contact Person Name
Welf Prager
Contact Person Email
science@derma-hamburg.de
Site Name
Praxis für Hautkrankheiten Dr. med. Eva Kristina Bee
Contact Person Name
Eva Kristina Bee
Contact Person Email
dr_bee@gmx.de
Site Name
Noahklinik GmbH
Contact Person Name
Ernst Magnus Noah
Contact Person Email
noah@drk-nh.de
Site Name
Haut und Lasercentrum Potsdam
Contact Person Name
Tanja Fischer

Spain

Earliest CTIS Part Ii Submission Date
19-06-2025
Latest Decision Or Authorization Date
03-02-2026
Processing Time Days
229
Number Of Sites
3
Number Of Participants
30

Sites

Site Name
Instituto Medico Ricart Valencia S.L.
Department Name
Dermatology
Contact Person Name
José María Ricart Vaya
Contact Person Email
sandra.march@imricart.com
Site Name
Clinica Universidad De Navarra
Department Name
Dermatology
Contact Person Name
Bernardo Carlos Hontanilla Calatayud
Contact Person Email
rvalencia@unav.es
Site Name
Dermomedic Center S.L.
Department Name
Dermatology
Contact Person Name
José Luis López Estebaranz
Contact Person Email
jlestebaranz@salud.madrid.org

France

Earliest CTIS Part Ii Submission Date
19-08-2025
Latest Decision Or Authorization Date
27-04-2026
Processing Time Days
251
Number Of Sites
3
Number Of Participants
30

Sites

Site Name
Cyrnos-Esthetique
Department Name
Not applicable
Contact Person Name
Philippe Kestemont
Contact Person Email
kphil69401@aol.com
Site Name
Bodokh Isaac
Department Name
Not applicable
Contact Person Name
Isaac Bodokh
Contact Person Email
isaacbodokh@yahoo.fr
Site Name
Aimed S.A.S.
Department Name
Not Applicable
Contact Person Name
Sophie Converset-Viethel
Contact Person Email
admin@drconverset-viethel.fr

Sponsor

Primary sponsor

Full Name
Merz Aesthetics GmbH
Organisation Type
Pharmaceutical company
Country Of Registered Address
Germany

Contract research organisations

Name
Almac Clinical Services (Ireland) Limited
Responsibilities
sponsorDuties codes: [14]; contact info: info@almacgroup.com
Name
Almac Clinical Services LLC
Responsibilities
sponsorDuties codes: [3]; contact info: IRTHelp@almacgroup.com
Name
Almac Clinical Services Limited
Responsibilities
sponsorDuties codes: [14]; contact info: info@almacgroup.com
Name
Icon Clinical Research Limited
Responsibilities
sponsorDuties codes: [1,12,2,5]; contact info: CTIS-Biotech@iconplc.com
Name
Metronomia Clinical Research GmbH
Responsibilities
sponsorDuties codes: [10,7]; contact info: info@metronomia.net
Name
LKF Laboratorium fuer Klinische Forschung GmbH
Responsibilities
sponsorDuties codes: [4]; contact info: project@lkf-kiel.de

Third parties

  • {"country":"Ireland","full_name":"Almac Clinical Services (Ireland) Limited","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"LKF Laboratorium fuer Klinische Forschung GmbH","duties_or_roles":"sponsorDuties codes: [4]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"sponsorDuties codes: [3]","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Metronomia Clinical Research GmbH","duties_or_roles":"sponsorDuties codes: [10,7]","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [1,12,2,5]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Transperfect Translations International Inc.","duties_or_roles":"eTMF","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"sponsorDuties codes: [14]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Canfield Scientific Inc.","duties_or_roles":"Clinical Photography","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Meeting Protocol Worldwide LP","duties_or_roles":"Patient travel reimbursement","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Bocouture (NT 201)
Active Substance
Clostridium botulinum neurotoxin type A (150kD), free of complexing proteins (incobotulinumtoxinA)
Modality
Peptide/protein/enzyme
Routes Of Administration
Intramuscular
Route
Intramuscular
Authorisation Status
Authorised (SmPC available)
Maximum Dose
Max daily: 96 U; Max total: 192 U
Investigational Product Name
Placebo excipients (sucrose and human serum albumin) reconstituted with sterile saline
Modality
Other

Related trials

Other published trials that may interest you.