Evaluate the Efficacy and Safety of INI101 Compared to BOTOX® in Subjects With Moderate to Severe Glabellar Lines.
1 de junio de 2026 actualizado por: INIBIO Co., Ltd.
A Multi-center, Double-blind, Randomized, Parallel, Active-controlled Phase III Trial to Evaluate the Efficacy and Safety of Botulinum Toxin Type A for Injection INI101 Compared to BOTOX® in Subjects With Moderate to Severe Glabellar Lines.
To evaluate the efficacy and safety of botulinum toxin type A for injection INI101 compared to BOTOX® in subjects with moderate to severe glabellar lines.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
292
Fase
- Fase 3
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
-
Seoul, Corea del Sur
- INIBIO Co., Ltd.
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- Adult male or female participants aged between 19 and 65 years old.
- Participants whose glabellar line score was 2 (moderate) or higher of glabellar line score at maximum frown based on the investigator's judgment at screening and randomization.
- Participants who voluntarily gave a consent in writing to participate in the clinical study with full knowledge of details of the study after listening to them.
- Participants who can understand and comply with the procedures and visit schedules of the study.
Exclusion Criteria:
- Systemic neuromuscular junction disorders (e.g., myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, hereditary motor neuropathy, etc.)
- History of blepharoplegia or ptosis
- Prominent facial asymmetry
- Glabellar lines that are physically difficult to be improved, such as the case where the lines are not removed by hands
- Participants who have received any drugs that can act as a systemic muscle relaxant within 4 weeks prior to screening
- Participants who have received anticoagulants, anti-platelet agents, or systemic NSAIDs within 7 days prior to administration of investigational products (however, low-dose aspirin [325 mg/day or less] administered for antithrombotic purposes is acceptable)
- Participants who have participated in other clinical trials of a drug/medical device within 30 days from participating in this clinical study and have been administered/treated with the investigational product/medical device
- Participants deemed ineligible for this study for other reasons based on the investigator's judgment
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Botulinum toxin type A (INI101)
|
Single administration, Day 0, 20 units
|
|
Comparador activo: Botulinum toxin type A (BOTOX®)
|
Administración única, Día 0, 20 unidades
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Improvement rate of glabellar lines at maximum frown according to the investigator's on-site assessment
Periodo de tiempo: Baseline to week 4
|
Investigator assessed the subject's glabellar lines 'At maximum frown' on a 4-point facial wrinkle scale (FWS) after 4 weeks of the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation.
|
Baseline to week 4
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Improvement rate of glabellar lines at maximum frown according to the investigator's on-site assessment
Periodo de tiempo: Baseline to week 8, 12, 16
|
Investigator assessed the subject's glabellar lines 'At maximum frown' on a 4-point facial wrinkle scale (FWS) at each time point after the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation.
|
Baseline to week 8, 12, 16
|
|
Improvement rate of glabellar lines at rest according to the investigator's on-site assessment
Periodo de tiempo: Baseline to week 4, 8, 12, 16
|
Investigator performed on-site assessment of the subject's glabellar lines 'At rest' on a 4-point facial wrinkle scale (FWS) at each time point after the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation.
|
Baseline to week 4, 8, 12, 16
|
|
Improvement rate of glabellar lines at maximum frown according to the independent assessor's photo assessment
Periodo de tiempo: Baseline to week 4, 8, 12, 16
|
Independent assessor assessed the subject's glabellar lines 'At maximum frown' ' on a 4-point facial wrinkle scale (FWS) at each time point after the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation.
An independent assessor separately conducted the FWS assessment subsequently based on the photographs taken.
|
Baseline to week 4, 8, 12, 16
|
|
Improvement rate of glabellar lines at rest according to the independent assessor's photo assessment
Periodo de tiempo: Baseline to week 4, 8, 12, 16
|
Independent assessor assessed the subject's glabellar lines 'At rest' on a 4-point facial wrinkle scale (FWS) at each time point after the administration of the investigational product compared to baseline, based on the Photo Guidelines for Glabellar Line Evaluation.
An independent assessor separately conducted the FWS assessment subsequently based on the photographs taken.
|
Baseline to week 4, 8, 12, 16
|
|
Improvement rate of glabellar lines as assessed by the subject
Periodo de tiempo: Baseline to week 4, 8, 12, 16
|
Subjects assessed their glabellar lines at each time point after the administration of the investigational product compared to baseline.
|
Baseline to week 4, 8, 12, 16
|
|
Subject's satisfaction
Periodo de tiempo: Baseline to week 4, 8, 12, 16
|
Subject's satisfaction score for the improvement of glabellar lines was investigated at each time point after the administration of the investigational product compared to before administration.
|
Baseline to week 4, 8, 12, 16
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
27 de mayo de 2021
Finalización primaria (Actual)
30 de enero de 2022
Finalización del estudio (Actual)
5 de marzo de 2022
Fechas de registro del estudio
Enviado por primera vez
26 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
27 de mayo de 2026
Publicado por primera vez (Actual)
2 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
1 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- NI101-PLN-CO-002
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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