- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00585286
Fractional Resurfacing Device for Treatment of Acne Scarring
Evaluation of a Novel Fractional Resurfacing Device for the Treatment of Acne Scarring
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Thirty subjects between two research locations with an acne scar severity score greater than 4 will receive up to 3 treatments with an FDA IDE and Institutional Review Board approved 10,600nm fractional carbon dioxide laser system. Improvement of acne scarring is evaluated at 1 month and 3 months post-treatment.
Post-treatment responses evaluated are immediate erythema, immediate edema, and any other immediate responses. Evaluations are conducted immediate post treatment and one week post-treatment. Key safety data include the severity scoring of post-treatment responses, as well as by photodocumentation.
The incidence of side effects such as scarring, pigmentary changes, etc. are evaluated at follow-up visits one and three months post-treatment. Key safety data include the incidence rates and severity scoring of side effects, as well as by photodocumentation
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Irvine, California, Estados Unidos, 92697
- UC Irvine Dermatology Clinical Research Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Have Fitzpatrick skin type I-V. (Type I is blonde/red hair with freckles and Type V are Hispanics and lighter African Americans.)
- Are male or female.
- Are between 18 and 75 years of age.
- Have moderate to severe acne scarring. Acne scarring will be assessed with the Acne Scar Severity Scale. Subjects will be eligible for treatment if the area to be treated is scored as having an Acne Scar Severity Score > 4 according to the Acne Scar Severity Scale (0-9).
- Are able to read, understand, and sign the Informed Consent.
- Are willing and able to comply with all follow-up requirements for a minimum of 8 months.
Exclusion Criteria:
- Have had active localized or systemic infections within 6 months of enrollment
- Have compromised ability for wound healing, such as: malnutrition, oral steroid use, history of collagen vascular disease (e.g. lupus, scleroderma, history of keloid formation (raised and thickened scars), atrophic dermatitis (extreme skin irritation or itchiness) or immunologic abnormalities such as vitiligo (white patches of skin due to loss of pigment)
- Have immunocompromised status (inability to resist infection, etc.)
- Have been treated with lasers, chemical procedures, or other cosmetic procedures on the area to be treated within 6 months of enrollment
- Have taken Accutane within 12 months of enrollment
- Are allergic to lidocaine (skin numbing agent)
- Are allergic to Valtrex (an anti-viral medication)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Fractional carbon dioxide laser system
Thirty total healthy subjects from two research centers with skin type I-IV of moderate to severe acne scarring received treatment with the 10,600 nm fractional carbon dioxide laser system.
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1-3 laser treatments using 20-100 millijoules (mJ) with 100-400 microscopic treatment zones (MTZ)/cm2 per pass and total density of 600-1200 MTZ/cm2
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Overall Improvement of Acne Scarring
Periodo de tiempo: Baseline, 1 month and 3 months post-treatment
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Subject assessment of the percent improvement of acne scarring compared to baseline and based on the quartile scale (0: no improvement; 1: 1-25% improvement; 2: 26-50%; 3: 51-75%; 4: 76-100% improvement).
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Baseline, 1 month and 3 months post-treatment
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Average Improvement in Surface Texture
Periodo de tiempo: Baseline, 1 month and 3 months post-treatment
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Subject assessment of the percent improvement of surface texture compared to baseline and based on the quartile scale (0: no improvement; 1: 1-25% improvement; 2: 26-50%; 3: 51-75%; 4: 76-100% improvement).
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Baseline, 1 month and 3 months post-treatment
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Degree of Atrophy
Periodo de tiempo: Baseline, 1 month and 3 months post-treatment
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Subject assessment of the percent improvement in extent of atrophy compared to baseline and based on the quartile scale (0: no improvement; 1: 1-25% improvement; 2: 26-50%; 3: 51-75%; 4: 76-100% improvement).
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Baseline, 1 month and 3 months post-treatment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Pain Tolerance
Periodo de tiempo: At treatment visit (up to 3 visits)
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The average pain score reported over all three treatments was 5.67, corresponding to "moderate" pain based on a 10-point scale.
The pain score is recorded on a 10-point scale, with 0 being "no pain" and 10 being "worst pain imaginable."
All subjects reported that any discomfort associated with the procedure was only during active intervention and resolved immediately post-procedure.
Increased pain scores correlated with increased density, but not increased energy.
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At treatment visit (up to 3 visits)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Christopher B Zachary, MBBS, FRCP, University of California, Irvine
- Investigador principal: Brian D Zelickson, MD, Department of Dermatology, University of Minnesota, Minneapolis, Minnesota
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2006-5328
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