1300 Participants NeededMy employer runs this trial

IPN10200 for Frown Lines

(LAURITE 2 Trial)

Recruiting at 59 trial locations
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called IPN10200, a new potential drug, to evaluate its effectiveness and safety in reducing frown lines (wrinkles between the eyebrows). The trial compares a single dose of IPN10200 to a placebo (a harmless, inactive substance) and examines the effects of repeated doses over time. Adults with moderate to severe frown lines who are dissatisfied with their appearance might be suitable candidates for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, certain medications that affect neuromuscular transmission, aminoglycoside antibiotics, and systemic retinoids are prohibited before and during the study. It's best to discuss your specific medications with the study investigator.

Is there any evidence suggesting that IPN10200 is likely to be safe for humans?

A previous study showed that IPN10200 was safe, with no safety concerns reported at any dose tested. Participants demonstrated a noticeable improvement in frown lines when using IPN10200 compared to a placebo. Importantly, researchers observed no major side effects, suggesting the treatment is safe for humans. This information may help potential participants feel more comfortable about the safety of IPN10200.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for frown lines, which typically involve botulinum toxin injections like Botox, IPN10200 presents a potentially new alternative. This treatment is administered via injection, similar to existing options, but researchers are excited because it may offer a different formulation or mechanism of action that could enhance effectiveness or reduce side effects. The investigation into IPN10200 could lead to a more refined approach to managing frown lines, providing patients with additional choices in their cosmetic treatments.

What evidence suggests that IPN10200 might be an effective treatment for glabellar lines?

Research has shown that IPN10200 effectively treats glabellar lines, the lines between the eyebrows. In this trial, participants in the IPN10200 group will receive the treatment via injection. Studies have found that IPN10200 improves these lines more effectively than a placebo. Four weeks after treatment, patients in those studies saw a noticeable improvement in their glabellar lines. No serious safety issues have been reported, making it a promising option for reducing these lines.12367

Are You a Good Fit for This Trial?

This trial is for adults (18+) with moderate to severe frown lines between the eyebrows who are unhappy with their appearance. Participants must be able to follow study instructions, give consent, and women must use contraception if required. People working on the study or living in institutions can't join.

Inclusion Criteria

I have moderate or severe GL at MF based on my doctor's assessment.
I am 18 years old or older.
I have moderate or severe GL at MF based on a doctor's assessment.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 20 days
At least 1 visit to the study centre

Treatment

Participants 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, eligible participants may receive additional cycles of IPN10200.

Varies, up to 52 weeks
Multiple visits during the first month followed by 1 visit every month

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks
Regular monitoring visits

Open-label extension

Participants may receive repeat doses of IPN10200 to evaluate long-term efficacy and safety

Up to 104 weeks
Visits at each post-treatment interval

What Are the Treatments Tested in This Trial?

Interventions

  • IPN10200

Trial Overview

The study compares a single dose of IPN10200 versus placebo for treating frown lines between the eyebrows. Later, all eligible participants may receive repeat doses of IPN10200 over several cycles to see how well it works and how safe it is long-term.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Corabotase groupExperimental Treatment1 Intervention
Group II: Placebo groupPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ipsen

Lead Sponsor

Trials
358
Recruited
74,600+
David Loew profile image

David Loew

Ipsen

Chief Executive Officer since 2020

BA in Business Administration and MBA from the University of St. Gallen, Switzerland

Sandra Silvestri profile image

Sandra Silvestri

Ipsen

Chief Medical Officer since 2023

MD, PhD

Citations

NCT07435428 | A Study to Assess the Effectiveness and ...

A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows (LAURITE 2).

Ipsen's IPN10200 Demonstrates Long-Lasting Efficacy in ...

IPN10200 demonstrated significant improvement in glabellar lines versus placebo, with a longer effect duration than Dysport, and no safety ...

A Study to Assess the Safety and Efficacy of IPN10200 in ...

The purpose of this study is to assess the safety and efficacy profile of increasing doses of IPN10200 in comparison to placebo.

Ipsen's IPN10200 Shows Superior Long-Term Efficacy in ...

Ipsen's internally developed IPN10200 demonstrated statistically significant improvement in glabellar lines at Week 4 versus placebo in the ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/29064991/

Efficacy of IncobotulinumtoxinA for the Treatment ...

Results: In the pooled analysis of Phase 3 GFL studies, 55.9% of males and 81.4% of females were responders on the Facial Wrinkle Scale (FWS) at 30 days.

Ipsen's LANTIC Phase II in aesthetics delivers a first-in- ...

IPN10200 was shown to be well-tolerated with no safety concerns reported with any of the evaluated doses of IPN10200 across Stage 1. Data will ...

IPN10200 for Frown Lines (LAURITE 2 Trial)

The purpose of this study is to assess the effectiveness and safety of a single dose of IPN10200 compared to placebo (double-blind phase) ...