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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство MASK LED
  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
• Комбинированный продукт LED MASK AND COSMETIC FORMULA
  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

Первичные конечные точки

• Improvement of anti-aging parameters [Срок оценки: baseline to 3 months]

Вторичные конечные точки (2)

• Global tolerance [Срок оценки: Immediate time to 3 months]
• Self assessment questionnaire [Срок оценки: immediat time to 3 months]

Критерии участия

Критерии включения

• Female subjects aged between 35-60y.o
• Presenting all skin types
• Presenting all phototype according to Fitzpatrick Classification
• Sensitive skin (50%) - declarative
• Daily user of SPF30 or 50+ for at least 30 days
• User or not of LED masks (collected data)
• Mask adapted to the shape of the face
• Having mild to moderate scores (as indicated) for the items parameters
• 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.
• Subjects willing to use the investigational devices and/or products on the face throughout the course of the study period
• Subjects taking an effective oral contraception or other methods of contraception for the duration of the study
• Written Informed Consent Form to participate in the study
• illingness and ability to comply with protocol requirements

Критерии исключения

• Subjects having allergy or sensitivity to LED Light
• Subjects having at risk of epilepsy
• subject who may have headaches
• Subjects having participated in the clinical study using anti-aging formula on the face within at least 3 months preceding the baseline visit
• Subjects having used any cosmetic products with exfoliating or astringing allegation on the face within at least 4 weeks preceding the baseline visit
• Subject with arterial circulatory disorders in the treated area,
• Subjects with sensitivity troubles and pain perception impairment, facial paralysis,
• Subjects with degenerative and vascular retinal disease,
• Subjects with known problems of scarring or wound healing,
• History of photosensitivity or photo allergy
• History of chronic viral infections (herpes simplex, ZONA…) and last outbreak within 12 months preceding the baseline visit
• Subject having an underlying dermatological disease or conditions on the face, which in the investigator's opinion, could interfere with study evaluation
• Subjects with a melanoma history in the family (parents or grandparents)
• Subjects undergone the radiotherapy in the treated areas,
• Subject having excessive moles, excessive pigmented spots, tattoos, scars, irritated skin, etc. at the test area that could influence the investigation
• Subject with a history of surgery to the treatment concerned areas within 6 months preceding the baseline visit
• 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).
• 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.
• 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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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Eurofins CRL — Piscataway

Идентификаторы

NCT: NCT07661004 · EV 2512-1248 MASK LED

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗