Study to Evaluate the Safety and Efficacy of IPN59011 in improving appearance of Moderate to Severe Upper Facial Lines

Phase 1

• Conditions: Treatment of Moderate to Severe Upper Facial Lines; MedDRA version: 21.1Level: LLTClassification code 10052609Term: Glabellar frown linesSystem Organ Class: 100000004858; MedDRA version: 21.1Level: LLTClassification code 10052610Term: Frown linesSystem Organ Class: 100000004858; Therapeutic area: Body processes [G] - Physical Phenomena [G01]

• Registration Number: EUCTR2019-003268-33-DE
• Lead Sponsor: Ipsen Innovation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-30
• Last Update Posted: 17 January 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 424

Inclusion Criteria

Subjects must fulfil all the following criteria to be included in the study:
(1) Provision of written informed consent prior to any study related procedures.
(2) Female and male subjects between 18 and 65 years of age, inclusive (for dose escalation, females only)
(3) Moderate or severe (Grade 2 or 3) GL at maximum contraction at Baseline, as assessed by the ILA using a validated 4-point photographic scale.
(4) Moderate or severe (Grade 2 or 3) GL at maximum contraction at Baseline, as assessed by the SSA using a validated 4-point categorical scale.
(5) Moderate or severe (Grade 2 or 3) FHL at maximum contraction and moderate to severe GL at maximum contraction at Baseline or moderate to severe (Grade 2 or 3) LCL at maximum contraction (Stage as assessed by the ILA using a validated 4-point photographic scale).
(6) Moderate or severe (Grade 2 or 3) FHL at maximum contraction and moderate to severe GL at maximum contraction at Baseline and moderate to severe (Grade 2 or 3) LCL at maximum contraction (Stage as assessed by the ILA using a validated 4-point photographic scale).
(7) Moderate or severe (Grade 2 or 3) FHL at maximum contraction and moderate to severe GL maximum contraction at Baseline or moderate to severe (Grade 2 or 3) LCL at maximum contraction, as assessed by the SSA using a validated 4-point categorical scale.
(8) Moderate or severe (Grade 2 or 3) FHL at maximum contraction and moderate to severe GL maximum contraction at Baseline and moderate to severe (Grade 2 or 3) LCL at maximum contraction, as assessed by the SSA using a validated 4-point categorical scale.
(9) Dissatisfied or very dissatisfied (Grade 2 or 3) with their lines at Baseline, as assessed by the subject’s level of satisfaction.
(10) A negative pregnancy test (for females of childbearing potential only). Non-childbearing potential is defined as postmenopausal for at least 1 year; surgical sterilisation at least 3 months before entering the study; or hysterectomy.
(11) Subject has both the time and the ability to complete the study and comply with study instructions.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 374
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Subjects will be excluded from the study if they meet any of the
following criteria:
(1) Previous treatment with any BTX serotype (for dose escalation) or any recent treatment (within the past 6 months prior to Baseline) with any BTX serotype.
(2) Any prior treatment with permanent fillers in the upper face
including the GL, FHL and LCL area.
(3) Any prior treatment with long lasting dermal fillers in the upper face including the GL 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 12 months prior to Baseline.
(4) Any planned facial cosmetic surgery during the study.
(5) A history of eyelid blepharoplasty or brow lift within the past 5
years.
(6) An inability to substantially reduce GL by physically spreading them apart or lack of capacity to frown.
(7) An active infection or other skin problems in the upper face including the GL, FHL and LCL area (e.g. acute acne lesions or ulcers).
(8) Use of concomitant therapy which, in the investigator's opinion,
would interfere with the evaluation of the safety or efficacy of the study treatment, including medications affecting bleeding disorders (e.g. antiplatelet agents and/or anticoagulants given for treatment or prevention of cardiovascular/cerebrovascular diseases).
(9) Pregnant women, nursing women, premenopausal women or women of childbearing potential (i.e. not surgically sterile or 1 year
postmenopausal) not willing to practice a highly effective form of
contraception method at the beginning of the study, for the duration of the study and for a minimum of 12 weeks following last administration of study treatment. Highly effective methods of contraception are defined as methods of birth control which result in a low failure rate (less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, intrauterine devices, or vasectomised partner.
(10) Male subjects who are not vasectomised and who have female
partners of childbearing potential and are not willing to use condoms with spermicide throughout study participation for a minimum of 12 weeks following initial double-blind administration of the treatment.
(11) Positive for hepatitis B antigen, or hepatitis C virus antibody, or for human immunodeficiency virus (HIV) or a diagnosis of acquired
immunodeficiency syndrome.
(12) A history of drug or alcohol abuse.
(13) Use of any experimental device within 30 days or use of any treatment with an experimental drug within five times the documented terminal half-life of the respective drug or its
metabolites or if the half-life is unknown within 30 days prior to the start of the study (prior to baseline) and during the conduct of the study.
(14) 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.
(15) Use of medications that affect neuromuscular transmission, such as curare-like nondepolarising agents, lincosamides, polymyxins, anticholinesterases and aminoglycoside antibiotics, within the past 30 days prior to Baseline.
(16) A history of facial nerve palsy.
(17) Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin.
(18) Known allergy or hypersensitivity to BTX, or any excipients of
IPN59011 or Azzalure, or aller

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified