Tolerability of Using a Post-Treatment Topical Adjuvant Combination Following Fractional Radiofrequency Ablation
15 de octubre de 2020 actualizado por: Venus Concept
Clinical Evaluation of the Tolerability of Using a Post Treatment Topical Adjuvant Combination Following Fractional Radiofrequency Ablation Using the Venus Viva
The purpose of this study is to compare the tolerability of the application of a combination of a serum containing human bone marrow stem cell derived growth factor (SCR Complex) and cytokines and a botanical lipid-based occlusive (Bio Cel) immediately following fractional radiofrequency treatment using the Venus Viva versus standard of care.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Randomized, open-label, multi-centre study to evaluate the tolerability of the application of a combination of a serum containing human bone marrow stem cell derived growth factor and cytokines (SCR Complex™) and a botanical lipid based occlusive (Bio Cel™) following facial fractional RF treatments using the Venus Viva™ SR system.
Each subject will receive 2 treatments separated by a 3-week interval.
Subjects will complete a VAS and Tolerability Scale immediately following each treatment.
Telephone follow-up calls by the site will ask the subject to respond to the Self-Report Adverse Event Questionnaire 24 and 72 hours after the first treatment and 24 hours after the second treatment.
Subjects will complete a Home Tolerability Scale 24 and 72 hours after the first treatment and 24 hours after the second treatment.
Subjects will return for the final FU visit and be asked to respond to the Self-Report Adverse Event Questionnaire and complete the Home Tolerability Scale for 72 hours.
The investigator will also evaluate the subject's improvement using the GAIS at this visit.
Tipo de estudio
Intervencionista
Inscripción (Actual)
49
Fase
- No aplica
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
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California
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Newport Beach, California, Estados Unidos, 92660
- Dr. George Taylor
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-
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
21 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Undergoing a dermatological procedure requiring ablation and resurfacing of the facial skin utilizing the Venus Viva™ SR system.
- Women of child-bearing age are required to be using a reliable method of birth control prior to enrollment and throughout their participation in the study.
- Able to tolerate the treatment as determined by a test spot application(s).
Exclusion Criteria:
- Superficial metal or other implants in the treatment area
- Tattoos, permanent makeup, scars or piercings in the treatment area.
- Any active condition in the treatment area, such as sores, psoriasis, eczema and rash.
- Any surgical procedure in the treatment area within the last three months or before complete healing.
- Receiving therapies or medication that may interfere with the study treatment.
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: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Topical combination therapy
Application of human bone marrow stem cell derived growth factor and cytokines serum followed by a botanical lipid-based occlusive immediately post-radio-frequency treatment of the face
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Otros nombres:
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Sin intervención: Standard of care
No topical therapies for 24 hours post-radio-frequency treatment of the face
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Subject Treatment Tolerability Score Post Treatment 1 at 24hrs Post Treatment
Periodo de tiempo: 24hr post treatment one
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Tolerability 5-point Likert scale where 4 - Very Tolerable, 3 - Tolerable, 2 - Having no opinion, 1 - Intolerable and 0 - very intolerable; The higher the score, the more tolerable the subject indicates the treatment is.
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24hr post treatment one
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Subject Treatment Tolerability Score Post Treatment 1 at 72hrs Post Treatment
Periodo de tiempo: 72 hrs post treatment one
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Tolerability 5-point Likert scale where 4 - Very Tolerable, 3 - Tolerable, 2 - Having no opinion, 1 - Intolerable and 0 - very intolerable; The higher the score, the more tolerable the subject indicates the treatment is.
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72 hrs post treatment one
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Subject Treatment Tolerability Score Post Treatment 2 at 24hrs Post Treatment
Periodo de tiempo: 24hr post treatment two
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Tolerability 5-point Likert scale where 4 - Very Tolerable, 3 - Tolerable, 2 - Having no opinion, 1 - Intolerable and 0 - very intolerable; The higher the score, the more tolerable the subject indicates the treatment is.
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24hr post treatment two
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Subject Treatment Tolerability Score Post Treatment 2 at 72 Hrs Post Treatment
Periodo de tiempo: 72hr post treatment two
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Tolerability 5-point Likert scale where 4 - Very Tolerable, 3 - Tolerable, 2 - Having no opinion, 1 - Intolerable and 0 - very intolerable; The higher the score, the more tolerable the subject indicates the treatment is.
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72hr post treatment two
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Visual Analog Scale
Periodo de tiempo: immediately following radio-frequency treatment
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10 cm Subject discomfort scale where 10 cm indicates 'Pain as bad as it can be' and 0 cm indicates there is no pain at all associated with the application of the treatment.
Zero pain means a better outcome.
Subjects were categorized as to having no pain (0 - 0.4cm), mild pain (0.5 - 4.4cm), moderate pain (4.5 - 7.4cm) and severe pain (7.5 - 10cm).
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immediately following radio-frequency treatment
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Fitzpatrick Wrinkle and Elastosis Scale
Periodo de tiempo: change in appearance of wrinkles from baseline and at end of study, average of 24 days
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Investigator assessment of improvement in wrinkles and elastosis where Class I indicates fine wrinkles, Class II indicates fine to moderate depth wrinkles with a moderate number of lines and Class III indicates fine to deep wrinkles, numerous lines with or without redundant skin folds with a score of 1 - 3 (Mild) indicates fine texture changes with subtly accentuated skin lines, a score of 4 - 6 (Moderate) indicates distinct papular elastosis ([indvidual papules with yellow translucency under direct lighting] and dyschromia and a score of 7 - 9 (Severe) indicates multipapular and confluent elastosis [thickened yellow and pallid] approaching or consistent with cutis rhomboidalis.
A lower class and a lower score means a better outcome.
Subjects were divided into 3 categories - No change in FWES score, change in FWES score by one and non-evaluable.
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change in appearance of wrinkles from baseline and at end of study, average of 24 days
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Global Aesthetic Improvement Scale
Periodo de tiempo: change in skin appearance between baseline and at end of study, average of 24 days
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Investigator assessment of aesthetic improvement where 1 shows exceptional improvement, 2 shows very improved, 3 shows improvement, 4 shows unchanged and 5 indicates that the subject appearance has worsened.
A low score means a better outome.
Subjects were categorized to either GAIS improved or GAIS no change.
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change in skin appearance between baseline and at end of study, average of 24 days
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Joseph L Reiz, BSc, Venus Concept Ltd.
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
1 de agosto de 2016
Finalización primaria (Actual)
1 de diciembre de 2016
Finalización del estudio (Actual)
27 de febrero de 2017
Fechas de registro del estudio
Enviado por primera vez
31 de agosto de 2016
Primero enviado que cumplió con los criterios de control de calidad
6 de septiembre de 2016
Publicado por primera vez (Estimar)
12 de septiembre de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de noviembre de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
15 de octubre de 2020
Última verificación
1 de octubre de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CS0116
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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