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

Overview

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

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.