- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07561242
Clinical Observational Study on Changes in Skin Physiological Parameters Following Ablative and Non-Ablative Fractional Laser Treatment at Different Doses
24 de abril de 2026 actualizado por: ChinaNorm
This clinical observational study investigates the dose-response relationship between laser energy intensity and skin damage/repair by applying different parameter sets of fractional ablative (CO2) and non-ablative (M22) lasers to the inner forearms of approximately 20 healthy Chinese female volunteers (aged 18-60, Fitzpatrick skin types III-V) in a single-center, self-controlled design.
Each participant receives both laser types on contralateral arms, with four distinct energy/density combinations per laser applied to separate test areas, and the dynamic skin responses are evaluated at baseline, immediately post-treatment, and at 30 minutes, 1, 2, 3, 4 hours, 7 days, and 10 days thereafter through clinical assessments (edema, erythema, etc.), standardized photography, high-frequency ultrasound (Dermascan), and objective instrumental measurements of skin color (Chromameter CM26dG), melanin/hemoglobin (Mexameter MX18), and barrier function (TEWL via Vapometer).
The collected data will be analyzed using descriptive and comparative statistical methods to characterize the acute injury and recovery profiles, aiming to establish a foundational model for future post-procedure cosmetic intervention research.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
De observación
Inscripción (Estimado)
20
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.
Estudio Contacto
- Nombre: Yanwen Jiang
- Número de teléfono: 13501700841
- Correo electrónico: jiangyanwen@china-norm.com
Ubicaciones de estudio
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200072
- Reclutamiento
- Shanghai China-norm Quality Technical Service Co., Ltd.
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Contacto:
- Wenqu Tang
- Número de teléfono: 13585634612
- Correo electrónico: tangwenqu@china-norm.com
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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
- Adulto
Acepta Voluntarios Saludables
Sí
Método de muestreo
Muestra no probabilística
Población de estudio
Approximately 20 healthy Chinese female volunteers, aged 18-60 years with Fitzpatrick skin phototypes III, IV, or V.
This population will serve as participants in a self-controlled, observational study to model laser-induced skin injury.
Each participant will receive both ablative (CO2) and non-ablative (M22) fractional laser exposures with varying parameters on their inner forearms to observe the dynamic physiological response and recovery process.
Descripción
Inclusion Criteria:
- Female Chinese study participants aged 18 to 60 years (inclusive).
- Fitzpatrick skin phototypes III, IV, or V.
- Willing to receive non-ablative fractional laser (M22) and ablative fractional laser (CO2) irradiation on the test sites during the study.
- No primary or secondary lesions (such as scars, ulcers, vesicles, tattoos) on the test sites.
- Has not participated in any other studies involving the test area (forearms) in the past 2 months.
- Agrees not to use skin-whitening products on the test area during the study period.
- In good general health at the time of the study.
- Volunteers to participate and signs the informed consent form and photo release authorization.
- Willing to comply with all requirements of the study.
Exclusion Criteria:
- Study participants with skin diseases or skin allergies in the test area.
- Presence of moderate to severe inflammatory skin diseases (e.g., active eczema, acute photosensitive dermatitis, etc.) on the test sites within the past 4 weeks, or those who require treatment with oral or topical corticosteroids or immunosuppressants for skin conditions.
- On the day of the visit, the investigator judges the presence of significant diffuse erythema, desquamation, or exudation in the test area that may significantly affect skin color measurement.
- The investigator assesses that the participant is currently suffering from a stable or progressively worsening disease.
- Participant is planning for pregnancy, is pregnant, or is breastfeeding (applicable to female participants only).
- Participant with immunodeficiency.
- Participant has a history of photosensitivity or photoallergy.
- Participant has a history of skin cancer or malignant melanoma.
- Presence of significant scars, tattoos, surgical incisions, or pigmented lesions (e.g., prominent birthmarks) in the test area that may affect assessment, and in the investigator's judgment, would impede normal imaging or scoring.
- Has used high-potency active products containing high concentrations of retinoic acid/retinol, alpha hydroxy acids, salicylic acid, etc., on the test area frequently (≥3 times per week) for an extended period (≥4 weeks) within the past 3 months, which, in the investigator's judgment, may significantly affect skin texture or barrier status.
- History of moderate to severe sun exposure (e.g., prolonged outdoor work, travel to seaside/high altitude) within the past 4 weeks, resulting in significant tanning or sunburn in the test area that, in the investigator's judgment, may interfere with study-related readings.
- Participation in other clinical or consumer testing projects involving the skin condition of the test area within the past 4 weeks.
- Presence of significant mental or cognitive impairment affecting compliance, and the investigator considers the participant unable to understand the study procedures or complete the tests as required.
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
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Change in Composite Clinical Skin Damage Score as Assessed by Clinician
Periodo de tiempo: From baseline (immediately before laser exposure) to 10 days post-exposure. Assessments are conducted at baseline (T0), immediately post-exposure (Timm), and 30 minutes, 1, 2, 3, 4 hours, 7 days (T7d), and 10 days (T10d) post-exposure.
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From baseline (immediately before laser exposure) to 10 days post-exposure. Assessments are conducted at baseline (T0), immediately post-exposure (Timm), and 30 minutes, 1, 2, 3, 4 hours, 7 days (T7d), and 10 days (T10d) post-exposure.
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Change in Skin Color Parameters (L, a, b*, ITA°) measured by Chromameter CM26dG
Periodo de tiempo: From baseline (immediately before laser exposure) to 10 days post-exposure. Assessments are conducted at baseline (T0), immediately post-exposure (Timm), and 30 minutes, 1, 2, 3, 4 hours, 7 days (T7d), and 10 days (T10d) post-exposure.
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From baseline (immediately before laser exposure) to 10 days post-exposure. Assessments are conducted at baseline (T0), immediately post-exposure (Timm), and 30 minutes, 1, 2, 3, 4 hours, 7 days (T7d), and 10 days (T10d) post-exposure.
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Change in Melanin and Hemoglobin Index measured by Mexameter MX18
Periodo de tiempo: From baseline (immediately before laser exposure) to 10 days post-exposure. Assessments are conducted at baseline (T0), immediately post-exposure (Timm), and 30 minutes, 1, 2, 3, 4 hours, 7 days (T7d), and 10 days (T10d) post-exposure.
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From baseline (immediately before laser exposure) to 10 days post-exposure. Assessments are conducted at baseline (T0), immediately post-exposure (Timm), and 30 minutes, 1, 2, 3, 4 hours, 7 days (T7d), and 10 days (T10d) post-exposure.
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Change in Transepidermal Water Loss (TEWL) measured by Vapometer
Periodo de tiempo: From baseline (immediately before laser exposure) to 10 days post-exposure. Assessments are conducted at baseline (T0), immediately post-exposure (Timm), and 30 minutes, 1, 2, 3, 4 hours, 7 days (T7d), and 10 days (T10d) post-exposure.
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From baseline (immediately before laser exposure) to 10 days post-exposure. Assessments are conducted at baseline (T0), immediately post-exposure (Timm), and 30 minutes, 1, 2, 3, 4 hours, 7 days (T7d), and 10 days (T10d) post-exposure.
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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)
21 de marzo de 2026
Finalización primaria (Estimado)
30 de abril de 2026
Finalización del estudio (Estimado)
30 de abril de 2026
Fechas de registro del estudio
Enviado por primera vez
13 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
24 de abril de 2026
Publicado por primera vez (Actual)
1 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
24 de abril de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- R26000004
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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