A study to assess the safety and efficacy of IPN10200 in adult participants with moderate to severe upper facial lines

Phase 1

Recruiting

• Conditions: Treatment of Moderate to Severe Upper Facial Lines; MedDRA version: 21.1Level: LLTClassification code: 10052609Term: Glabellar frown lines Class: 10040785; Therapeutic area: Phenomena and Processes [G] - Physical Phenomena [G01]; MedDRA version: 21.1Level: LLTClassification code: 10052610Term: Frown lines Class: 10040785

• Registration Number: CTIS2024-512782-14-00
• Lead Sponsor: Ipsen Innovation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-10
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 727

Inclusion Criteria

Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent., Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol., Participant has both the time and the ability to complete the study and comply with study instructions., Does not reside in an institution by administrative or court order., Is not a sponsor employee or clinical research unit personnel directly affiliated with the study or is not an immediate family member. Immediate family is defined as a spouse, parent, child or sibling whether biological or legally adopted., 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., 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., 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)., 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)., 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., 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., Dissatisfied or very dissatisfied (Grade 2 or 3) with their lines at Baseline, as assessed by the SLS., Male and female participants (only female for dose escalation). Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. • Male participants: Male participants must agree that, if their partner is at risk of becoming pregnant, they will use an effective method of contraception. The participants must agree to use the contraception during the whole period of the study and for 12 weeks after the study intervention injection. • Female participants: A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: -Is a woman of non-childbearing potential (WONCBP) as defined in Appendix 4 Contraception and Barrier Guidance. OR -Is a WOCBP and using an acceptable contraceptive method as described in Appendix 4: Contraceptive and Barrier Guidance during the study intervention period (at a minimum until after the last dose of study intervention). The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention o A WOCBP must have a negative highly sensitive pregnancy test at Baseline ([urine or serum]) as required by local regulations). Non- childbearing potential is d

Exclusion Criteria

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)., Any planned facial cosmetic surgery during the study., Use of concomitant therapy which, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study intervention, including medications affecting bleeding disorders (e.g. antiplatelet agents and/or anticoagulants given for treatment or prevention of cardiovascular/cerebrovascular diseases)., 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 prior to Baseline. Topical use of for example aminoglycoside medications on the face apart from the area of injection would be acceptable., 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 halflife is unknown within 30 days prior to the start of the study (prior to Baseline) and during the conduct of the study., Known positive for hepatitis B antigen, or hepatitis C virus antibody, or for human immunodeficiency virus (HIV) or a diagnosis of acquired immunodeficiency syndrome., Clinically diagnosed significant anxiety disorder, or any other significant psychiatric disorder (e.g. depression) that might interfere with the participant's participation in the study, An inability to substantially lessen GL and/or horizontal forehead rhytids even by physically spreading them apart as determined by the investigator., Known allergy or hypersensitivity to BoNT, or any excipients of IPN10200 or Dysport/Azzalure, or allergy to cow's milk protein., A history of drug or alcohol abuse., 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 intervention. 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 vasectomized partner., A history of eyelid blepharoplasty or brow lift within the past 5 years, Male participants 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., Any uncontrolled systemic disease or other significant medical condition which would be harmful for the participant to be entered into the study or continue participation., A history of facial nerve palsy., Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring, or thick sebaceous skin., Any known medical condition that may put the participant at increased risk in regard to exposure to BoNT of any serotype (i.e. myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, etc.), Has COVID-19 illness or a known positive SARS-CoV-2 test, or the presence of any other condition (e.g. neuromuscular disord

Study & Design

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