A Study to Assess the Effectiveness and Safety of IPN10200 Over Time in Adults With Moderate to Severe Wrinkle-like Lines Between the Eyebrows
Condition(s) studied
Investigational drug(s) / intervention(s)
Corabotase: A single vial of lyophilised powder for solution for injection will be injected locally into several sites across the glabellar region.
Placebo: 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 summary
The purpose of this study is to assess the effectiveness and safety of a single dose of Corabotase (also known as IPN10200) compared to placebo (double-blind phase) and how well and safely repeat doses of Corabotase 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 Corabotase 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 Corabotase 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 Corabotase or placebo. In the open-label phase (rollover participants from double-blind), eligible participants may receive additional cycles of Corabotase . In the open-label phase (de novo participants), participants will receive Corabotase in the first cycle and eligible participants may receive additional cycles of Corabotase. 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.
Eligibility
Primary outcome measure(s)
- For North America: Percentage of participants responding to treatment — At week 4
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 — From baseline to week 4
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."
Trial sites (60)
| Facility | City | Region | Status |
|---|---|---|---|
| Rivkin Westside Aesthetics | Los Angeles | California | |
| Clinical Testing of Beverly Hills | Los Angeles | California | |
| Eye Research Foundation | Newport Beach | California | |
| Steve Yoelin MD Medical Associates Inc | Newport Beach | California | |
| Skin and Beauty Center | Pasadena | California | |
| Dermatology Cosmetic Laser Medical Associates of La Jolla Inc. | San Diego | California | |
| Southern California Dermatology, Inc. | Santa Ana | California | |
| DMR Research, PLLC | Westport | Connecticut | |
| Center for Dermatology and Dermatologic Surgery | Washington D.C. | District of Columbia | |
| Skin and Cancer Associates (SCA) and the Center for Cosmetic Enhancement (CCE) - Aventura | Aventura | Florida | |
| Weinkle Dermatology | Bradenton | Florida | |
| Skin Research Institute | Coral Gables | Florida | |
| Miami Dermatology & Laser Research | Miami | Florida | |
| Kavali Plastic Surgery and Skin Renewal Center | Atlanta | Georgia | |
| DeNova Research | Chicago | Illinois | |
| Chicago Cosmetic and Dermatologic Research | Chicago | Illinois | |
| Advanced Dermatology, A Forefront Dermatology Practice | Lincolnshire | Illinois | |
| LASSI - Laser and Skin Surgery Center of Indiana | Indianapolis | Indiana | |
| Coleman Center For Cosmetic Dermatologic Surgery | Metairie | Louisiana | |
| DelRicht Research | New Orleans | Louisiana | |
| Etre, Cosmetic Dermatology and Laser Center | New Orleans | Louisiana | |
| Maryland Laser, Skin, & Vein Institute, LLC (MDLSV) | Hunt Valley | Maryland | |
| Lawrence J. Green, MD. LLC | Rockville | Maryland | |
| SkinCare Physicians | Chestnut Hill | Massachusetts | |
| Michigan Center for Research Company | Clarkston | Michigan | |
| Skin Specialists PC dba Schlessinger MD | Omaha | Nebraska | |
| StracSkin | Portsmouth | New Hampshire | |
| Rejuva Center at Williams | Latham | New York | |
| The Center for Dermatology, Cosmetic & Laser Surgery | Mount Kisco | New York | |
| Luxurgery | New York | New York | |
| Dr. Z. Paul Lorenc MD, Office Of | New York | New York | |
| Skin Search Of Rochester, Inc. | Rochester | New York | |
| Rochester Dermatologic Surgery, P.C. | Victor | New York | |
| Aesthetic Solutions P.A. | Chapel Hill | North Carolina | |
| Dermatology, Laser & Vein Specialists of the Carolinas (DLVSC) - Charlotte Office | Charlotte | North Carolina | |
| Nash Research Group, LLC | Powell | Ohio | |
| Oregon Dermatology and Research Center | Portland | Oregon | |
| Paddington Testing Company | Philadelphia | Pennsylvania | |
| Brian S. Biesman MD, PLLC | Nashville | Tennessee | |
| Tennessee Clinical Research Center | Nashville | Tennessee |
+ 20 more sites — see the full list on the official registry below.
More Ipsen trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07435428 on ClinicalTrials.gov ↗ ← All trials in France