Treatment of Moderate to Severe Upper Facial Lines
Conditions
Brief summary
1. Incidence, severity, and nature, at each dose, of the TEAEs, SAEs, AEs (or SAEs) leading to discontinuations and AESIs., 2. Vital signs, 3. Facial and physical examination., 4. ECG, 5. Response to treatment as measured by the composite response of 2- grade improvement on both ILA and SSA at maximum contraction on the studied area at Week 4
Detailed description
1. Response to treatment as measured by the reduction of ≥2 grades on the ILA at maximum contraction at each post treatment visit for each concerned facial area., 2. Response to treatment as achieved by a score of "none" or "mild" as measured by the ILA at maximum contraction at each post treatment visit for each concerned facial area., 3. Response to treatment as achieved by a score of "none" or "mild" simultaneously for all three facial areas as measured by the ILA at maximum contraction at Week 4., 4. Response to treatment as achieved by a score of "none" or "mild" as measured by the ILA at rest at each post-treatment visit for each concerned facial area., 5. Response to treatment as measured by the reduction of ≥2 grades on the SSA at maximum contraction at each post-treatment visit for each concerned facial area., 6. Response to treatment as achieved by a score of "none" or "mild" as measured by the SSA at maximum contraction at each post treatment visit for each concerned facial area., 7. Response to treatment as achieved by a score of "very satisfied" or "satisfied" on the SLS at each post treatment visit., 8. Time to onset of treatment response based on participant diary cards., 9. The duration of treatment response based on the ILA and SSA at maximum contraction at each post treatment visits., 10. Satisfaction with facial appearance scale score at post‑treatment visits V6, V8, V10, V13, V16 based on Face-Q satisfaction scale., 11. At each post treatment visits: Incidence, severity, and nature of the TEAEs, SAEs, AEs (or SAEs) leading to withdrawals and AESIs., 12. At each post treatment visits: Physical and facial examination, 13. At each post treatment visits: Vital signs, 14. At post treatment visits V8, V13, V16: Presence of IPN10200 antibodies and titres (binding and neutralising), 15. Response to treatment as achieved by a score of “none” or “mild” as measured by the SSA at rest at each post treatment visit (Stage 2)., 16. Open-label Phase: Incidence, severity, and nature of the TEAEs, SAEs, AEs (or SAEs) leading to discontinuations and AESIs, 17. Open-label Phase: Clinically significant changes in vital signs, facial and focused neurological/physical examination compared to baseline, 18. Open-label Phase: Response to treatment as measured by the composite response of 2-grade improvement on both the ILA and SSA at maximum contraction at each post treatment visit within each cycle, 19. Open-label Phase: Response to treatment as measured by the reduction of ≥2 grades on the ILA at maximum contraction at each post treatment visit within each cycle, 20. Open-label Phase: Response to treatment as achieved by a score of “none” or “mild” as measured by the ILA at maximum contraction at each post treatment visit within each cycle, 21. Open-label Phase: Response to treatment as achieved by a score of “none” or “mild” as measured by the ILA at rest at each post treatment visit within each cycle, 22. Open-label Phase: Response to treatment as measured by the reduction of ≥2 grades on the SSA at maximum contraction at each post treatment visit within each cycle, 23. Open-label Phase: Response to treatment as achieved by a score of “none” or “mild” as measured by the SSA at maximum contraction at each post treatment visit within each cycle, 25. Open-label Phase: Response to treatment as achieved by a score of “very satisfied” or “satisfied” on the SLS at each post treatment visit within each cycle, 26. Open-label Phase: The time between two consecutive injections, 27. Open-label Phase: Presence of IPN10200 antibodies and titres (binding and neutralising)
Interventions
Sponsors
Ipsen Innovation
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence, severity, and nature, at each dose, of the TEAEs, SAEs, AEs (or SAEs) leading to discontinuations and AESIs., 2. Vital signs, 3. Facial and physical examination., 4. ECG, 5. Response to treatment as measured by the composite response of 2- grade improvement on both ILA and SSA at maximum contraction on the studied area at Week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Response to treatment as measured by the reduction of ≥2 grades on the ILA at maximum contraction at each post treatment visit for each concerned facial area., 2. Response to treatment as achieved by a score of "none" or "mild" as measured by the ILA at maximum contraction at each post treatment visit for each concerned facial area., 3. Response to treatment as achieved by a score of "none" or "mild" simultaneously for all three facial areas as measured by the ILA at maximum contraction at Week 4., 4. Response to treatment as achieved by a score of "none" or "mild" as measured by the ILA at rest at each post-treatment visit for each concerned facial area., 5. Response to treatment as measured by the reduction of ≥2 grades on the SSA at maximum contraction at each post-treatment visit for each concerned facial area., 6. Response to treatment as achieved by a score of "none" or "mild" as measured by the SSA at maximum contraction at each post treatment visit for each concerned facial | — |
Countries
France, Germany
Outcome results
None listed