A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Moderate to Severe Upper Facial Lines
Condition(s) studied
Investigational drug(s) / intervention(s)
Corabotase: Stage 1: Several different doses will be administrated in a dose-escalation manner. One single injection will be injected locally into several sites across the glabellar region. Stage 2: One single injection will be injected locally into several sites across the glabellar, forehead and lateral Canthal regions. Stage 3: One single injection will be injected locally into several sites across the upper facial area.
IPN10200 Placebo: Stage 1: One single injection of study intervention will be injected locally into several sites across the glabellar region. Stage 2: One single injection will be injected locally into several sites across the glabellar, forehead and lateral Canthal regions. Stage 3: One single injection will be injected locally into several sites across the upper facial area.
Dysport: Single administration of study intervention in stage 1 / step 2 and 3 only
Study summary
The purpose of this study is to assess the safety and efficacy profile of increasing doses of Corabotase (also known as IPN10200) in comparison to placebo, with the aim to discover the doses(s) that offer the best efficacy/safety profile when used for the treatment of moderate to severe Upper Facial Lines.
This study will be conducted in three stages. The full study (including all stages) will have a maximum 727 participants.
Stage 1 (phase Ib \& II)
* Step 1 (Phase Ib): a dose-escalation first-in-human step in participants with moderate to severe Glabellar Lines (GL)
* Step 2 (Phase II): dose ranging step in participants with moderate to severe GL as compared with Dysport
* Step 3 (Phase II): dose finding step in participants with moderate to severe GL as compared with Dysport, followed by an open label (OL) phase for the highest dose cohort to assess the long-term safety and efficacy of Corabotase. In the OL phase, participants may receive repeat administrations of Corabotase for up to three additional cycles (up to four treatment cycles in total during the study).
Stage 2 (phase II) - An evaluation of efficacy and safety of Corabotase in one of the following regions: GL + forehead lines (FHL), forehead lines (FHL) or lateral canthal lines (LCL)
Stage 3 (phase II)
\- A safety and efficacy evaluation of Corabotase in all three regions (GL, FHL and LCL)
Eligibility
Primary outcome measure(s)
- Incidence of treatment emergent adverse events (TEAEs) at each dose — From the baseline to the end of the study (9 months)
At Stage 1/Step 1, Stage 3 - Incidence of serious adverse events (SAEs) at each dose — From the baseline to the end of the study (9 months)
At Stage 1/Step 1, Stage 3 - Incidence of Adverse Events (AEs) (or SAEs) leading to withdrawals and Adverse Events of Special Interest (AESIs) — From the baseline to the end of the study (9 months)
At Stage 1/Step 1, Stage 3 - Response to treatment at Stage 2 for the FHL group — At Week 4
Measured by the composite response of ≥ 2-grade improvement on Investigator's Live Assessment (ILA) and subject's self-assessment (SSA) at maximum contraction on the forehead lines: ILA: a validated 4-point photographic scale to assess the severity and appearance of the Forehead Lines (FHL) at maximum frown and at rest where 0 is "none" and 3 is "severe" SSA: a validated 4-point categorical scale to assess the appearance of their FHLs at maximum frown where 0 is "no wrinkles" and 3 is "severe wrinkles" - Response to treatment at Stage 2 for the glabellar lines (GL)+ FHL group — At Week 4
Measured by the composite response of ≥ 2-grade improvement on ILA and SSA at maximum contraction on the forehead lines (FHL) area: ILA: a validated 4-point photographic scale to assess the severity and appearance of the GLs and FHLs at maximum frown and at rest where 0 is "none" and 3 is "severe" SSA: a validated 4-point categorical scale to assess the appearance of their GLs and FHLs at maximum frown where 0 is "no wrinkles" and 3 is "severe wrinkles" - Response to treatment at Stage 2 for the LCL group — At Week 4
Measured by the composite response of ≥ 2-grade improvement ILA and SSA at maximum contraction on both sides of the lateral canthal lines (LCL) area: ILA: a validated 4-point photographic scale to assess the severity and appearance of the LCLs at maximum frown and at rest where 0 is "none" and 3 is "severe" SSA: a validated 4-point categorical scale to assess the appearance of their LCLs at maximum frown where 0 is "no wrinkles" and 3 is "severe wrinkles" - Percentage of Participants With Clinically Significant Changes from baseline in Vital Signs — From the baseline to the end of the study (6 years, 5 months)
Double Blind phase. Clinically significant changes in vital signs will be reported. The clinical significance will be graded by the investigator. - Percentage of participants with clinically significant Change from baseline in 12-lead Electrocardiogram (ECG) readings — From the baseline to the end of the study (6 years, 5 months)
Double Blind phase. - Percentage of participants with clinically significant change from baseline in facial and focused neurological/physical examination. — From the baseline to the end of the study (6 years, 5 months)
Double Blind phase. Clinically significant changes in facial examination and focused neurological/physical examinations will be reported. The clinical significance will be graded by the investigator.
Trial sites (10)
| Facility | City | Region | Status |
|---|---|---|---|
| MEDITI - Clinique Del Mar | Antibes | France | |
| Aimed S.A.S | Lyon | France | |
| Clinique de Chirurgie Esthétique Iéna | Paris | France | |
| Interdisciplinary Study Association | Kassel | State of Berlin | |
| CRS Clinical Research Services Berlin GMBH | Berlin | Germany | |
| Interdisciplinary Study Association | Berlin | Germany | |
| ROSENPARK RESEARCH GmbH | Darmstadt | Germany | |
| Privatpraxis Dr. Hilton & Partner | Düsseldorf | Germany | |
| Fachbereich Chemie Institut für Biologie und Molekularbiologie Studiengang Kosmetikwissenschaft | Hamburg | Germany | |
| Dermatologische Gemeinschaftspraxis Blankenfelde-Mahlow | Mahlow | Germany |
More Ipsen trials in Germany
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 NCT04821089 on ClinicalTrials.gov ↗ ← All trials in Germany