A Study to Assess the Effectiveness and Safety of IPN10200 in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows

Conditions

• Moderate to Severe Glabellar Lines

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• IPN10200 — BIOLOGICAL
  A single vial of lyophilised powder for solution for injection will be injected locally into several sites across the glabellar region.
• Placebo — BIOLOGICAL
  A single vial of lyophilised powder for solution, containing excipients without active substance, will be injected locally into several sites across the glabellar region.

Study Details

The purpose of this study is to assess the effectiveness and safety of IPN10200 compared to placebo in the improvement of the appearance of moderate to severe glabellar lines in adult participants. 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. In this study, all participants will receive a single injection of either IPN10200 or placebo (the study drug). 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 (Day 1) where all the eligible participants will receive a single injection of IPN10200 or placebo. * A follow-up period (52 weeks) where participants' health will be monitored, consisting of regular visits to the study centre and 1 telephone call visit. 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 55 weeks. Participants may withdraw consent to participate at any time.

Key Dates

Start date

Feb 27, 2026

Status verified

Apr 2026

Primary completion

Dec 15, 2026

Completion

Jul 15, 2027

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: IPN10200 group
  Participants will receive IPN10200 through injections into the selected muscles on Day 1.
• Placebo Comparator: Placebo group
  Participants will receive placebo through injections into the selected muscles on Day 1.

Primary Outcome Measure

For North America: Percentage of participants responding to treatment [ Time Frame: From baseline to week 4 ]

Central Contacts

• Ipsen Recruitment Enquiries
  see email
  [email protected]

Locations (17)

Find similar trials in Birmingham, AL

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• A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
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