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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 czerwca 2026 zaktualizowane przez: 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

Przegląd badań

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

130

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

    • New Jersey
      • Piscataway, New Jersey, Stany Zjednoczone, 08854
        • Eurofins CRL

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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)

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Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Model interwencyjny: Zadanie sekwencyjne
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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
Aktywny komparator: 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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Improvement of anti-aging parameters
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Global tolerance
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

1 kwietnia 2027

Ukończenie studiów (Szacowany)

1 kwietnia 2027

Daty rejestracji na studia

Pierwszy przesłany

16 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

16 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

22 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

22 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

16 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • EV 2512-1248 MASK LED

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

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

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Tak

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Przeciw starzeniu

Badania kliniczne na MASK LED

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