A Study to Assess the Effectiveness and Safety of IPN1020... | NCT07427797

Status Module

Description Module

Label	Type	Description	Intervention Names
IPN10200 group	Experimental	Participants will receive IPN10200 through injections into the selected muscles on Day 1.	Biological: IPN10200
Placebo group	Placebo Comparator	Participants will receive placebo through injections into the selected muscles on Day 1.	Biological: Placebo

Name	Type	Description	Arm Group Labels	Other Names
IPN10200	Biological	A single vial of lyophilised powder for solution for injection will be injected locally into several sites across the glabellar region.	IPN10200 group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
For North America: Percentage of participants responding to treatment	Measured by the multicomponent response of ≥2-grade improvement from baseline and a score of 'None' or 'Mild' on Investigator's Live Assessment (ILA) and Subject's Self-Assessment (SSA) at maximum frown ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe." SSA: a 4-point categorical scale used to assess the appearance of glabellar lines at maximum frown, where grade 0 = "No wrinkles," grade 1 = "Mild wrinkles," grade 2 = "Moderate wrinkles," and grade 3 = "Severe wrinkles.	From baseline to week 4
For EU and ROW: Percentage of participants responding to treatment	Measured by a ≥2-grade improvement on Investigator's Live Assessment (ILA)at maximum frown ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe."	From baseline to week 4

Secondary Outcomes

Measure	Description	Time Frame
For North America: Percentage of participants responding to treatment	Measured by the multicomponent response of ≥2-grade improvement from baseline and a score of 'None' or 'Mild' on Investigator's Live Assessment (ILA) and Subject's Self-Assessment (SSA) at maximum frown. ILA: a validated 4-point photographic scale used to assess the severity and appearance of glabellar lines at maximum frown, where grade 0 = "None," grade 1 = "Mild," grade 2 = "Moderate," and grade 3 = "Severe." SSA: a 4-point categorical scale used to assess the appearance of glabellar lines at maximum frown, where grade 0 = "No wrinkles," grade 1 = "Mild wrinkles," grade 2 = "Moderate wrinkles," and grade 3 = "Severe wrinkles.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant should be male or female, ≥18 years of age inclusive at the time of signing the ICF.
Moderate or severe (Grade 2 or 3) GL at MF at baseline, as assessed by the ILA using a validated 4-point photographic scale.
Moderate or severe (Grade 2 or 3) GL at MF at baseline, as assessed by the SSA using a 4-point categorical scale.
Dissatisfied or very dissatisfied (Grade 2 or 3) with their lines at baseline, as assessed by the SLS.
For female participants: Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the 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.

Exclusion Criteria:

An active infection or other skin problems in the upper face including the GL area (e.g. acute acne lesions or ulcers).
A history of eyelid blepharoplasty or brow lift or any other upper facial surgery within the past 5 years.
A history of facial nerve palsy.
Marked facial asymmetry, ptosis, excessive dermatochalasis, deep dermal scarring or thick sebaceous skin.
Presence of any scars, piercings or tattoos (including micro blading of the eyebrows) in or around the treatment area that have occurred within 6 months prior to baseline, or which in the investigator's opinion, could interfere with evaluations.
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.).
Administration of any BoNT (other than the study intervention on baseline visit) into any site of the body and for any indication from 9 months prior to the first study visit until the end of the study.
Participants who have received IPN10200 in a previous study.
Use of medications that affect neuromuscular transmission (such as curare-like nondepolarising agents, lincosamides, polymyxins, anticholinesterases) within the past 30 days prior to baseline are prohibited or a longer washout period of at least five half-lives might be required, as deemed appropriate by the investigator for long-acting medications.
Use of aminoglycoside antibiotics within the past 30 days prior to baseline are prohibited. Note: Topical use apart from the area of injection would be acceptable.
Use of systemic retinoids within the past 30 days prior to baseline and planned use during the study. Note: Topical retinoids are allowed other than in the areas that will be injected (upper facial area) at the discretion of the investigator.
Any prior treatment with permanent fillers, lifting threads, autologous fat or permanent procedures in the upper face including the GL area.
Administration of any non-permanent injectables (such as hyaluronic acid, calcium hydroxylapatite, poly-L-Lactic acid or polymethyl-methacrylate) soft tissue augmentation therapy in the GL region within 12 months prior to baseline.
Any prior facial treatment or aesthetic procedures to the upper face including photo rejuvenation, vascular or pigment laser or microneedling within the 3 months prior to baseline.
Any prior facial treatment or aesthetic procedures to the upper face involving skin resurfacing (including dermabrasion, laser or whatever the interventional technique used) or chemical peel within the past 12 months prior to baseline.
Any planned cosmetic surgery or aesthetic procedures to the upper face during the study and/or any procedures to other parts of the face which in the investigator's opinion, could interfere with evaluations during the study.
Any past surgery in the UFL area including GL.
Planned use of concomitant therapy which, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study intervention. Therapy considered necessary for the participant's welfare may be given at the discretion of the investigator. Note: If the permissibility of a specific medication/treatment is in question, the medical monitor will be contacted.
Use of any experimental device within 30 days prior to baseline visit 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 visit) and during the conduct of the study.
Known positive for hepatitis B antigen, hepatitis C virus antibody or for human immunodeficiency virus 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 as determined by the investigator.
Known allergy or hypersensitivity to BoNT or any excipients of IPN10200.
A history of chronic or recreational drug abuse as assessed by the investigator.
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.