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Not Yet Recruiting NCT07661004

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

Conditions: Photodamage of the Face, Anti Aging

Sex: Female
Ages: 35 Years – 60 Years
Healthy volunteers: No
Phase: NA
Enrollment: 130
Sponsor: L'Oreal

Location: Eurofins CRL Piscataway New Jersey

Summary

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

Eligibility Criteria

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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Source: ClinicalTrials.gov (NCT07661004). StuddyBuddy aggregates publicly available trial information.