NCT07779252 - A Study to Assess the Effectiveness and Safety of IPN10200 in Adult Chinese Participants With Moderate to Severe Wrinkle-like Lines Between the Eyebrows | Crick

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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. * If 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. * 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.). * Closed-angle glaucoma or a predisposition to it. * Participants who have received IPN10200 in a previous study. * Administration of any BoNT (other than the study intervention at the baseline visit) into any site of the body and for any indication from 9 months prior to the first study visit until the EOS * 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.

Outcomes

Primary Outcomes

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.

Time frame: At Week 4

Secondary Outcomes

Percentage of participants responding to treatment as measured by a score of 'None' or 'Mild' at Week 24 on the 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."

Time frame: At Week 24

Percentage of participants responding to treatment

Time frame: From baseline to each post-treatment visit except Week 4 (up to 55 Weeks)

Percentage of participants responding to treatment as measured by a score of 'None' or 'Mild' on the ILA at maximum frown at each post treatment visit except Week 24.

Time frame: From baseline to each post-treatment, except Week 24 (up to 55 Weeks)

Percentage of participants responding to treatment as measured by a score of 'None' or 'Mild' on the SSA at maximum frown at each post treatment visit.

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.

Time frame: From baseline to each post-treatment (up to 55 Weeks)

Percentage of participants with ≥1-grade improvement on the ILA at maximum frown at each post treatment visit

Time frame: From baseline to each post-treatment visit (up to 55 Weeks)

Percentage of participants with ≥1-grade improvement on the SSA at maximum frown at each post treatment visit

Time frame: From baseline to each post-treatment visit (up to 55 Weeks)

Percentage of participants with ≥1-grade improvement on the ILA at rest at each post treatment visit

Time frame: From baseline to each post-treatment visit (up to 55 Weeks)

Percentage of participants satisfied with their facial appearance after the treatment as measured by a score of 'Very Satisfied' or 'Satisfied' on Subject's Level of Satisfaction (SLS)

SLS: a 4-point categorical scale used to assess satisfaction with the appearance of glabellar lines, where grade 0 = "Very satisfied," grade 1 = "Satisfied," grade 2 = "Dissatisfied," and grade 3 = "Very dissatisfied."

Time frame: From baseline to each post-treatment visit (up to 55 Weeks)

Percentage of participants with change from baseline in psychological function, as measured by Psychological Well-Being Scale on FACE-Q

FACE-Q Psychological Function Scale: a validated 4-point categorical scale used to assess participants' psychological well-being. The scale consists of statements about how participants feel about themselves, with responses indicating the level of agreement on a 4-point scale ranging from "strongly disagree" to "strongly agree."

Time frame: From baseline to each post-treatment visit (up to 55 Weeks)

Time to onset of treatment response based on subject diary to evaluate the appearance of their lines

Participants record in a diary whether they notice an improvement in the appearance of their glabellar lines, with responses captured as Yes/No.

Time frame: At baseline and daily from Day 1 to Day 8 (Week 1)

Time taken for a responder to re-exhibit their baseline severity grade on the ILA at maximum frown

Responder is defined as having a score of 'None' or 'Mild' on the ILA. 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."

Time frame: At all timepoints post-injection (Day 1) until end of study (up 55 Weeks)

Time taken for a responder to re-exhibit a severity grade of 'Moderate' or 'Severe' as measured by the ILA at maximum frown