- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01713998
Treatment of the Face and Neck With Lower Ulthera System Energy Settings
Evaluation of the Ulthera® System for Lifting and Tightening the Face and Neck With Lower Energy Settings
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Arizona
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Mesa, Arizona, Estados Unidos, 85210
- Ulthera, Inc.
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Male or female, age 30 to 65 years.
- Subject in good health.
- Skin laxity on the face and neck
Exclusion Criteria:
- Presence of an active systemic or local skin disease that may affect wound healing.
- Severe solar elastosis.
- Excessive subcutaneous fat in the face or neck.
- Excessive skin laxity on the face or neck.
- Significant scarring in areas to be treated.
- Open wounds or lesions in the area to be treated.
- Severe or cystic acne on the area to be treated.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Ativo: Group A
Subjects will receive an increased density Ulthera System Treatment over the full face but with the energy turned down to the second highest level of four possible energy settings on one side of the face.
|
Energia de ultrassom focada fornecida abaixo da superfície da pele
Outros nomes:
|
Comparador Ativo: Group B
Subjects will receive an increased density guideline Ulthera System Treatment over the full face but with the energy turned down to the lowest level of four possible energy settings on one side of the face.
|
Energia de ultrassom focada fornecida abaixo da superfície da pele
Outros nomes:
|
Comparador Ativo: Group C
Subjects will receive an increased density guideline Ulthera System Treatment over the full face with the exception that a 4 MHz transducer will be used on the upper face in place of a7 MHz transducer, with the energy turned down to the lowest level of four possible energy settings.
|
Energia de ultrassom focada fornecida abaixo da superfície da pele
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Subjects' Assessment of Pain During Treatment With Lower Energy Settings
Prazo: Participants were assessed for the duration of study treatment, an average of 75 minutes
|
Subjects' sensory response to the Ulthera treatment exposures were recorded using a validated Numeric Rating Scale (NRS,0-10), for each anatomical region treated and energy settings used, with 0 representing no pain and 10 representing the worst pain possible. Pain scores were collected in a consistent manner, following treatment of each section of the face and neck on both sides (submental, submandibular, cheek, periorbital, infraorbital, and forehead), and for each transducer used. Split-face comparisons of pain scores obtained during study treatment by research staff blinded to the energy settings used were completed. |
Participants were assessed for the duration of study treatment, an average of 75 minutes
|
Overall Improvement in Skin Laxity on the Face and Neck
Prazo: 90 days post-treatment
|
A split-face comparison of improvement in overall lifting and tightening of skin was completed by three masked assessors.
Pre-treatment and 90 days post-treatment photos from 45 subjects who returned for their 90-day follow-up visit were reviewed, assessing for improvement in skin laxity, i.e., lifted and tightened skin in the areas treated using treatment energy settings based on subjects' assigned study group.
|
90 days post-treatment
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Quantitative Assessment of Brow Lift at 90 Days Post-treatment
Prazo: 90 days post-treatment
|
Quantitative assessment and analysis of brow lift from baseline to 90 days post-treatment was completed comparing brow lift achieved using standard energy settings compared to adjusted energy settings.
The number of subjects with 1 mm or more brow lift is reported.
Note: Because the submental region was treated using standard energy settings in all study groups, a quantitative analysis of lift in this region between the study groups would most likely not be informative, and therefore was not completed.
|
90 days post-treatment
|
Subject Assessment of Improvement at 90 Days Post-treatment
Prazo: 90 days post-treatment
|
Subjects completed a Patient Assessment Questionnaire at 90 days post-treatment by referring to their image in a mirror, their 90-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck.
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90 days post-treatment
|
Subject Assessment of Improvement at 180 Days Post-treatment
Prazo: 180 days post-treatment
|
Subjects completed a Patient Assessment Questionnaire at 180 days post-treatment by referring to their image in a mirror, their 180-day post-treatment photos, and their pre-treatment photos, and reporting if any improvement was noted on the right and left sides of their face and neck.
|
180 days post-treatment
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Steven H Gitt, MD, Ulthera, Inc
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
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 (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ULT-300
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