The purpose of this study is to assess the effectiveness and safety of a single dose of IPN10200 compared to placebo (double-blind phase) and how well and safely repeat doses of IPN10200 work over time (open-label phase) in adult participants with moderate to severe glabellar lines. Glabellar lines are wrinkle-like lines that appear between the eyebrows and can become more noticeable with age or repeated facial expressions. They may affect a person's appearance and confidence.
All participants in the double-blind phase will receive IPN10200 or placebo during the first treatment cycle. De novo participants in the open-label phase will receive IPN10200 during the first treatment cycle. Some participants may receive additional treatment cycles with IPN10200 depending on their eligibility.
There will be 3 periods in this study:
* A screening period (up to 20 days) to assess whether the participant can take part, requiring at least 1 visit to the study centre. * A treatment period where participants may receive up to 4 treatment cycles. In the double-blind phase, participants receive a single treatment of IPN10200 or placebo. In the open-label phase (rollover participants from double-blind), eligible participants may receive additional cycles of IPN10200. In the open-label phase (de novo participants), participants will receive IPN10200 in the first cycle and eligible participants may receive additional cycles of IPN10200. Requires multiple visits during the first month followed by 1 visit every month. * A follow-up period (24 weeks) after the last injection where participants' health will be monitored.
Participants will undergo health measurements and observation, including blood sampling, physical examinations, clinical evaluations and electrocardiograms (ECG: recording of the electrical activity of heart). They will also be asked to fill in questionnaires and keep a diary.
Each participant will be in this study for up to 107 weeks. Participants may withdraw consent to participate at any time.
Participant should be male or female, ≥18 years of age at the time of signing the informed consent.
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.
Are 'dissatisfied' or 'very dissatisfied' with their GLs at baseline, as assessed by the SLS score.
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.
Parallel
IPN10200
Biological/VaccineA single vial of lyophilised powder for solution for injection will be injected locally into several sites across the glabellar region.
Placebo
Biological/VaccineA single vial of lyophilised powder for solution, containing excipients without active substance, will be injected locally into several sites across the glabellar region.
For North America: Percentage of participants responding to treatment
Measured by the multi-component response of ≥2-grade improvement 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."
For EU and ROW: Percentage of participants responding to treatment as measured by ≥2-grades improvement 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."
For Double Blind (DB) phase: For North America: Percentage of participants responding to treatment
Measured by the composite response of ≥2-grade improvement and a score of 'None' or 'Mild' on ILA and SSAat 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."
For DB phase: Percentage participants responding to treatment as measured by a score of "None" or "Mild on 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."
For DB phase: Percentage of participants responding to treatment as measured by a score of "None" or "Mild on SSA at maximum frown
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."
For DB phase: For all regions except United States: 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 validated 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."
