Efficacy and Safety of Botulinum Toxin Type A Haemagglutinin Complex Next Generation (BTX-A-HAC NG) in Glabellar Lines

NCT02493946 | Completed Phase 3 Results

• 2 other identifiers: Y-52-52120-2142014-003841-86
• Study Type: interventional
• Target: 600
• Locations: 3 countries
• Sites: 24

Brief Summary

The purpose of the protocol is to demonstrate the safety and the efficacy of a single injection of a new formulation of Clostridium Botulinum toxin type A haemagglutinin complex (BTX A HAC NG) to improve the appearance of moderate to severe glabellar lines (the lines between the eyebrows) and to assess the long term efficacy and safety of BTX-A-HAC NG after repeated injections.

Conditions

Glabellar Lines

Outcome Measures

Primary Outcomes (1)

• The Percentage of Responders at Day 29 Cycle 1 as Measured by Investigator's Live Assessment (ILA) of Glabellar Lines at Maximum Frown: DB Period

  The appearance of glabellar lines at maximum frown was assessed in the DB period at the Day 29 follow-up visit using the ILA, a validated 4-point photographic scale of glabellar line severity. A responder was defined as having a severity grade of none (Grade 0) or mild (Grade 1) at a given visit and a severity grade of moderate (Grade 2) or severe (Grade 3) at baseline (Day 1 Cycle 1). The adjusted percentage of responders (determined by multivariate logistic regression analysis) at Day 29 of Cycle 1 is presented.

  Day 29 (Cycle 1)

Secondary Outcomes (17)

• The Percentage of Responders at Each Post-treatment Visit (Except Day 29 Cycle 1) as Measured by the ILA at Maximum Frown: DB Period

  Days 8, 57 and 85 (Cycle 1).

• The Percentage of Responders on Day 29 Cycle 1 Who Remained Responders on Days 57 and 85 as Measured by the ILA at Maximum Frown: DB Period

  Days 29, 57 and 85 (Cycle 1).

• The Percentage of Responders at Each Post-treatment Visit to the Study Centre as Measured by the ILA at Rest: DB Period

  Days 8, 29, 57 and 85 (Cycle 1).

• The Percentage of Responders at Each Post-treatment Visit to the Study Centre as Measured by the Subject's Self-Assessment (SSA) at Maximum Frown: DB Period

  Days 8, 29, 57 and 85 (Cycle 1).

• The Percentage of Responders at Each Post-treatment Visit to the Study Centre as Measured by the Subject's Level of Satisfaction With the Appearance of Their Glabellar Lines: DB Period

  Days 8, 29, 57 and 85 (Cycle 1).

Study Arms (2)

BTX-A-HAC NG

EXPERIMENTAL

Clostridium Botulinum Toxin Type A (BTX A HAC NG), total treatment volume 0.25mL will be divided into 5 injections (0.05mL per injections) injected in 5 pre-defined sites across the glabellar region. A total of 50 Units of BTX-A-HAC NG will be injected/ cycle.

Biological: Botulinum toxin type A

Placebo

PLACEBO COMPARATOR

The total placebo volume 0.25mL will be divided into 5 injections (0.05mL per injections) injected in 5 pre-defined sites across the glabellar region. Administered in Cycle 1 of the double blind phase only.

Drug: Placebo

Interventions

Botulinum toxin type A BIOLOGICAL

Also known as: BTX-A-HAC NG

BTX-A-HAC NG

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of written informed consent prior to any study related procedures.
• Male or female subjects between 18 and 65 years of age.
• Have moderate or severe (Grade 2 or 3) vertical glabellar lines at maximum frown at Baseline (Day 1), as assessed by the ILA using a validated 4- point photographic scale.
• Have moderate or severe (Grade 2 or 3) vertical glabellar lines at maximum frown at Baseline (Day 1), as assessed by the SSA using a validated 4-point categorical scale.
• Are dissatisfied or very dissatisfied (Grade 2 or 3) with their glabellar lines at Baseline (Day 1), as assessed by the subject's level of satisfaction.
• Have a negative pregnancy test (for females of childbearing potential only). No childbearing potential is defined as post-menopausal for at least 1 year, surgical sterilisation at least 3 months before entering the study, or hysterectomy.
• Have both the time and the ability to complete the study and comply with study instructions.

You may not qualify if:

• Previous treatment with any serotype of BTX.
• Any prior treatment with permanent fillers in the upper face including the glabellar lines area.
• Any prior treatment with any dermal fillers in the upper face including the glabellar lines area within the past 3 years and/or skin abrasions/resurfacing (whatever the interventional technic used) within the past 5 years, or photo rejuvenation or skin/vascular laser intervention within the past 12 months.
• Any planned facial cosmetic surgery during the study.
• A history of eyelid blepharoplasty or brow lifts within the past 5 years.
• An inability to substantially reduce glabellar lines by physically spreading them apart or lack of capacity to frown.
• An active infection or other skin problems in the upper face including the glabellar lines area (e.g. acute acne lesions or ulcers).
• Use of concomitant therapy, which in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the investigational medicinal product (IMP), including medications affecting bleeding disorders (antiplatelet agents and/or anticoagulants given for treatment or prevention of cardio/cerebro vascular diseases).
• Pregnant women, nursing mothers, or women who are planning a pregnancy during the study, or believe they may be pregnant at the start of the study. Throughout the course of the study, women of childbearing potential must use a reliable form of contraception (e.g. oral contraceptives for more than 12 consecutive weeks, or spermicide and condoms).
• Treatment with an experimental drug or use of any experimental device within 30 days prior to the start of the study and during the conduct of the study.
• Known allergy or hypersensitivity to any component of BTX-A-HAC NG.
• Clinically diagnosed significant anxiety disorder, or any other significant psychiatric disorder (e.g. depression) that might interfere with the subject's participation in the study.
• Use of medications that affect neuromuscular transmission, such as curare-like non depolarising agents, lincosamides, polymyxins, anticholinesterases and aminoglycoside antibiotics, within the past 30 days.
• A history of facial nerve palsy.
• Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (24)

Centre Médical Saint-Jean

Arras, 62000, France

Location

CHRU Hôpital

Besançon, 25000, France

Location

Cabinet Médical

Cannes, 06400, France

Location

MEDITI/ Clinique Science et Beauté, Villa Sylvana

Juan-les-Pins, 06160, France

Location

Palais de Flore

Lyon, 69006, France

Location

Clinique Iéna

Paris, 75116, France

Location

Dermatologisches Studienzentrum

Berlin, Germany

Location

Privatpraxis für Dermatologie und ästhetische Medizin

Berlin, Germany

Location

Klinik

Darmstadt, Germany

Location

Rosenpark Research

Darmstadt, Germany

Location

Medical Skin Center

Düsseldorf, Germany

Location

Klinik für Dermatologie

Frankfurt, Germany

Location

Abteilung Biochemie und Molekularbiologie Fachrichtung Kosmetikwissenschaft

Kassel, Germany

Location

Rote Kreuz Krankenhaus

Kassel, Germany

Location

Klinik

Ludwigshafen, Germany

Location

Hautarztpraxis Mahlow

Mahlow, Germany

Location

Universitäts-Hautklinik der Gutenberg Universität Mainz

Mainz, Germany

Location

Privatpraxis für Dermatologie und Ästhetik

München, Germany

Location

Praxisklinik

Münster, Germany

Location

Klinische Forschung Osnabrück

Osnabrück, Germany

Location

Hautzentrum am Starnberger See

Starnberg, Germany

Location

Praxis für Dermatologie und Venerologie

Wuppertal, Germany

Location

London Bridge Plastic Surgery

London, United Kingdom

Location

PHI clinic

London, United Kingdom

Location

Related Publications (1)

• Hilton S, Kestemont P, Sattler G, Volteau M, Thompson C, Andriopoulos B, Prygova I, Berg AK, Ascher B. Liquid AbobotulinumtoxinA: Pooled Data From Two Double-Blind, Randomized, Placebo-Controlled Phase III Studies of Glabellar Line Treatment. Dermatol Surg. 2022 Nov 1;48(11):1198-1202. doi: 10.1097/DSS.0000000000003594. Epub 2022 Oct 7.

  PMID: 36206385 DERIVED

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Medical Director, Neurology
• Organization: Ipsen

clinical.trials@ipsen.com

Study Officials

• Ipsen Study Director

  Ipsen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: July 10, 2015
• Study Start: April 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2016
• Last Updated: September 28, 2022
• Results First Posted: May 28, 2019

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
• Access Criteria: Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/)

Locations

DE (16); GB (2); FR (6)