Finding of Optimal Dose for NT 201 in the Treatment of Glabellar Frown Lines
A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Determine the Optimal Dose of NT 201, Free of Complexing Proteins, in the Treatment of Glabellar Frown Lines
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Frankfurt, Alemanha, 60318
- Merz Pharmaceuticals GmbH
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Moderate to severe glabellar frown lines
Exclusion Criteria:
- Previous insertion of permanent material in the glabellar area
- Neuromuscular function disease
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador de Placebo: Placebo
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Single treatment with Placebo given as intramuscular treatment injections of equal amount to 5 sites on Day 0. A volume of reconstituted 0.6 mL per subject was administered.
The total dose volume was administered in equal aliquots to the 5 injection sites.
Thus, each of the 5 injection sites was injected with 0.12 mL Placebo per injection site.
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Experimental: 20 U NT 201
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Single treatment with 10, 20 or 30 Units of NT 201 given as intramuscular treatment injections of equal amount to 5 sites on Day 0. The same volume of reconstituted study medication (0.6 mL per subject) was administered irrespective of the treatment group.
The total dose volume was administered in equal aliquots to the 5 injection sites.
Thus, each of the 5 injection sites was injected with 0.12 mL study medication per injection site.
Outros nomes:
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Experimental: 10 U NT 201
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Single treatment with 10, 20 or 30 Units of NT 201 given as intramuscular treatment injections of equal amount to 5 sites on Day 0. The same volume of reconstituted study medication (0.6 mL per subject) was administered irrespective of the treatment group.
The total dose volume was administered in equal aliquots to the 5 injection sites.
Thus, each of the 5 injection sites was injected with 0.12 mL study medication per injection site.
Outros nomes:
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Experimental: 30 U NT 201
|
Single treatment with 10, 20 or 30 Units of NT 201 given as intramuscular treatment injections of equal amount to 5 sites on Day 0. The same volume of reconstituted study medication (0.6 mL per subject) was administered irrespective of the treatment group.
The total dose volume was administered in equal aliquots to the 5 injection sites.
Thus, each of the 5 injection sites was injected with 0.12 mL study medication per injection site.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of responders at maximum frown at Day 30 as assessed by the investigator according to Facial Wrinkle Scale (FWS)
Prazo: Baseline (Day 0) to Day 30
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Responders on the FWS are defined as subjects with glabellar line severity of none (0) or mild (1). The Primary Analysis Set (PAS) will be used for all confirmatory tests for the primary efficacy variables of the co-primary endpoint. The PAS will consist of all subjects in the Full Analysis Set who have available assessments by the investigator for severity of glabellar frown lines at maximum frown on Day 30, as well as patient's assessment at Day 0 and Day 30. All analyses for this population will therefore use the same sample for both primary endpoints. |
Baseline (Day 0) to Day 30
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Percentage of responders at maximum frown at Day 30 as assessed by patient's assessment according to 4-point scale
Prazo: Baseline (Day 0) to Day 30
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Responders will be subjects with at least a 1-point improvement compared to Day 0. The Primary Analysis Set (PAS) will be used for all confirmatory tests for the primary efficacy variables of the co-primary endpoint. The PAS will consist of all subjects in the Full Analysis Set who have available assessments by the investigator for severity of glabellar frown lines at maximum frown on Day 30, as well as patient's assessment at Day 0 and Day 30. All analyses for this population will therefore use the same sample for both primary endpoints. |
Baseline (Day 0) to Day 30
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of responders at maximum frown at Day 90 as assessed by the investigator according to FWS
Prazo: Baseline (Day 0) to Day 90
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Responders on the FWS are defined as subjects with glabellar line severity of none (0) or mild (1). Secondary efficacy endpoints will be analyzed analogously to the analysis of primary efficacy endpoint. |
Baseline (Day 0) to Day 90
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Percentage of responders at maximum frown at Day 90 as assessed by patient's assessment
Prazo: Baseline (Day 0) to Day 90
|
Responders will be subjects with at least a 1-point improvement compared to Day 0. Secondary efficacy endpoints will be analyzed analogously to the analysis of primary efficacy endpoint. |
Baseline (Day 0) to Day 90
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Cadeira de estudo: Merz Pharmaceuticals, Merz Pharmaceuticals GmbH
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Efeitos Fisiológicos das Drogas
- Agentes Neurotransmissores
- Mecanismos Moleculares de Ação Farmacológica
- Agentes do Sistema Nervoso Periférico
- Agentes colinérgicos
- Moduladores de transporte de membrana
- Inibidores da Liberação de Acetilcolina
- Agentes Neuromusculares
- Toxinas Botulínicas
- Toxinas Botulínicas, Tipo A
- toxina abobotulínica A
- incobotulínica toxina A
Outros números de identificação do estudo
- MRZ 60201-0527/1
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