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Evaluation of the Efficacy and Tolerability of the LED Mask With or Without the Serum Formula on the Signs of Facial Photodamage .

16 de junio de 2026 actualizado por: L'Oreal

Evaluation of the Efficacy and Tolerability of the LED Mask With or Without the Serum Formula on the Signs of Facial Photodamage

Main objective : To evaluate the anti-aging effectiveness of the LED mask alone on at least one studied anti-aging parameters (including some targeted wrinkles) after 3 months versus baseline

Secondary objectives:

  • Anti-aging clinical score (radiance, skin tone, fine line, ptose, plumpness, ..)
  • Evaluate the consumer perception (self-evaluation)
  • Tolerance
  • Standardized pictures (all light) and pictures analysis
  • Comparison of effectiveness between the 2 groups (with and without formula

Descripción general del estudio

Descripción detallada

Rational Photodamaged/aged facial skin is characterized by thinner and drier skin, with increasing sags and wrinkles due to the loss of collagen and elastic tissue. Aging skin is also much more susceptible to the development of brown spots and pigmentation.

The use of LED masks to combat skin aging is based on a scientific principle called photobiomodulation. Red and near-infrared light stimulates cellular repair mechanisms without heating or damaging tissues. Its safety profile is well-documented across all skin types and side effects of phototherapy have been shown as being minimal and temporary.

Design:

Prospective, monocentric, open, non-randomized study conducted in healthy female participant aged 35 to 60 years.

The clinical investigation is design to evaluate the efficacy and tolerability of a LED mask with or without a serum formula on the anti-aging signs of the face.

There are 2 different groups:

Group 1: investigational device alone /Group 2: investigational device + cosmetic serum. Inclusion in each group will not be randomized but will be sequential: group 1 first and then group 2.

the evaluation times are : baseline, Timmedialy, after 7 days (D7), after one month (T1M), after 2 months (T2M), after 3 months (3M) Reglementation The clinical investigation will be conducted in compliance with Good Clinical Practice (GCP) guidelines and applicable regulatory requierement for medical device investigation, ISO 14155 Statistic Safety analyses will be performed on the SS population, while efficacy analyses will be primary performed on the ITT population. If the sample size between the PP and ITT differs by more than 10%, the efficacy analysis will also be performed on the PP population.

Evaluations criterias Clinical Grading of Efficacy Parameters Assessed with scale 10 grade -point scale (0-9) or atlas photonumeric for the items : Fine lines, Roughness , Skin tone evenness, Radiance , Plumpness, Firmness, Suppleness, Elasticity, Forehead wrinkles, Glabella wrinkles, Crow's feet wrinkles, Wrinkles on the corner of lips, Ptosis on the lower face , Nasolabial fold.

The significant change versus baseline for each item will be evaluated at each time point.

The self assessment efficacy questionnaire:

The answers to the efficacy questionnaire will be summarized in the frequency table by category , together with 100% stacked bar charts.

Safety Assessment AEs will be listed by participant including time of onset, time from the first administration of clinical investigation drug, duration, intensity, action taken, corrective therapies, outcomes, relationship to clinical investigation drug and serousness.

Th dermatologist will assess the overall tolerance on a 4-grade (Very good (1); Good (2); Moderate (3); Bad (4)) at each visits.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

130

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.

Estudio Contacto

Ubicaciones de estudio

    • New Jersey
      • Piscataway, New Jersey, Estados Unidos, 08854
        • Eurofins CRL

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

No

Descripción

Inclusion Criteria:

  1. Female subjects aged between 35-60y.o
  2. Presenting all skin types
  3. Presenting all phototype according to Fitzpatrick Classification
  4. Sensitive skin (50%) - declarative
  5. Daily user of SPF30 or 50+ for at least 30 days
  6. User or not of LED masks (collected data)
  7. Mask adapted to the shape of the face
  8. Having mild to moderate scores (as indicated) for the items parameters
  9. Subjects willing not to change their face/eyes make-up removal products and habits, and shower habits (e.g. shampoo, shower gel), and make-up products (eyes and mouth) throughout the course of the study.
  10. Subjects willing to use the investigational devices and/or products on the face throughout the course of the study period
  11. Subjects taking an effective oral contraception or other methods of contraception for the duration of the study
  12. Written Informed Consent Form to participate in the study
  13. illingness and ability to comply with protocol requirements

Exclusion Criteria:

  1. Subjects having allergy or sensitivity to LED Light
  2. Subjects having at risk of epilepsy
  3. subject who may have headaches
  4. Subjects having participated in the clinical study using anti-aging formula on the face within at least 3 months preceding the baseline visit
  5. Subjects having used any cosmetic products with exfoliating or astringing allegation on the face within at least 4 weeks preceding the baseline visit
  6. Subject with arterial circulatory disorders in the treated area,
  7. Subjects with sensitivity troubles and pain perception impairment, facial paralysis,
  8. Subjects with degenerative and vascular retinal disease,
  9. Subjects with known problems of scarring or wound healing,
  10. History of photosensitivity or photo allergy
  11. History of chronic viral infections (herpes simplex, ZONA…) and last outbreak within 12 months preceding the baseline visit
  12. Subject having an underlying dermatological disease or conditions on the face, which in the investigator's opinion, could interfere with study evaluation
  13. Subjects with a melanoma history in the family (parents or grandparents)
  14. Subjects undergone the radiotherapy in the treated areas,
  15. Subject having excessive moles, excessive pigmented spots, tattoos, scars, irritated skin, etc. at the test area that could influence the investigation
  16. Subject with a history of surgery to the treatment concerned areas within 6 months preceding the baseline visit
  17. Subject reports (or plans to) sunbath or overexpose to UV-light (mountains sports, phototherapy, tanning salon use…) for aesthetic or therapeutic reason one month before the study start (or during the study).
  18. Subject having modified their cosmetic habits (moisturizing skin care, cleansers, make-up removers, make-up, shower products, shampoo…) during the 2 weeks before baseline visit.
  19. Subject uses or has used any of the medications or topical treatments/skincare products/procedure below without relevant wash-out period before the baseline visit (or is unwilling or unable to accept to follow the wash-out period below during the study)

    -

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: No aleatorizado
  • Modelo Intervencionista: Asignación Secuencial
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: ARM 1 : MASK LED ALONE
Participant aged between 40 and 55 years who presents signs of photodamage on the face as well as anti-aging signs (wrinkles, complexion, luminosity)
Application of mask LED on the face, 5 times a week for 10 minutes for 3 months. The participant will apply his usual moisturizer and sunscreen
Comparador activo: ARM2 : DEVICE + COSMETIC FORMULA
Participant aged between 40 and 55 years who presents signs of photodamage on the face as well as anti-aging signs (wrinkles, complexion, luminosity)
application of the LED mask 5 times a week during 10 minutes and the cosmetic formula twice a day for 3 months Paticipant will apply his usual moisturizer and sunscreen

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Improvement of anti-aging parameters
Periodo de tiempo: baseline to 3 months
The expert clinical grading will perform a standartied clinical evaluation oth the 14 anti-aging items with the scale 10 grade -point scale (0-9) or L'Oréal Skin Aging Atlas (scale photonumeric)
baseline to 3 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Global tolerance
Periodo de tiempo: Immediate time to 3 months
The investigator will assign an overall tolerance score at each visit using the following scale 1: very good ; 2: good ; 3: Moderate ; 4 : Bad
Immediate time to 3 months
Self assessment questionnaire
Periodo de tiempo: immediat time to 3 months
Participant will complete a subjective evaluation questionnaire to capture their perception of treatment outcomes. The questionnaire, using a 5 point scale (1= Disagree to 5= Agree), will include items on visible results (confort, ease of use, improvement in overall skin appereance, satisfaction)
immediat time to 3 months

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 (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

1 de abril de 2027

Finalización del estudio (Estimado)

1 de abril de 2027

Fechas de registro del estudio

Enviado por primera vez

16 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

16 de junio de 2026

Publicado por primera vez (Actual)

22 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

16 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • EV 2512-1248 MASK LED

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Data confidentiality, not provided for in the consent to participation, application of the GDPR

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.

Sí

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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