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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
NCT07435428 · View on ClinicalTrials.gov ↗
Study Summary
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 conse
Conditions Studied
Interventions
- BIOLOGICAL IPN10200
- BIOLOGICAL Placebo
Study Locations (20)
California
- Rivkin Westside Aesthetics — Los Angeles
- Clinical Testing of Beverly Hills — Los Angeles
- Eye Research Foundation — Newport Beach
- Steve Yoelin MD Medical Associates Inc — Newport Beach
- Skin and Beauty Center — Pasadena
- Dermatology Cosmetic Laser Medical Associates of La Jolla Inc. — San Diego
- Southern California Dermatology, Inc. — Santa Ana
Florida
- Skin and Cancer Associates (SCA) and the Center for Cosmetic Enhancement (CCE) - Aventura — Aventura
- Weinkle Dermatology — Bradenton
- Skin Research Institute — Coral Gables
- Miami Dermatology & Laser Research — Miami
Illinois
- DeNova Research — Chicago
- Chicago Cosmetic and Dermatologic Research — Chicago
- Advanced Dermatology, A Forefront Dermatology Practice — Lincolnshire
Louisiana
- Coleman Center For Cosmetic Dermatologic Surgery — Metairie
- DelRicht Research — New Orleans
Connecticut
- DMR Research, PLLC — Westport
District of Columbia
- Center for Dermatology and Dermatologic Surgery — Washington D.C.
Georgia
- Kavali Plastic Surgery and Skin Renewal Center — Atlanta
Indiana
- LASSI - Laser and Skin Surgery Center of Indiana — Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,300 participants |
| Start Date | 2026-02-18 |
| Est. Completion | 2028-10-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07435428
The ClinicalTrials.gov registry entry for NCT07435428 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ipsen, which has 205 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Moderate to Severe Glabellar Lines appearing as the primary indexed condition, and to 2 interventions — of which IPN10200 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07435428 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07435428 about?
NCT07435428 is a clinical study titled "A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows". 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 ...
What is the current status of trial NCT07435428?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,300 participants. The study started on 2026-02-18. Estimated completion is 2028-10-01.
What conditions does trial NCT07435428 study?
This clinical trial studies the following conditions: Moderate to Severe Glabellar Lines. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07435428?
The interventions under investigation include: IPN10200 (BIOLOGICAL), Placebo (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07435428?
This trial is sponsored by Ipsen, which has 205 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07435428 being conducted?
This trial has 20 study locations across California, Connecticut, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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