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

NCT07661004 | Not Yet Recruiting FDA Device

• 1 other identifier: EV 2512-1248 MASK LED
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Photodamage of the Face; Anti Aging

Keywords

WRINKLES; SAFETY; EFFICACY; MASK LED; CONSUMER PERCEPTION

Outcome Measures

Primary Outcomes (1)

• Improvement of anti-aging parameters

  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

Secondary Outcomes (2)

• Global tolerance

  Immediate time to 3 months

• Self assessment questionnaire

  immediat time to 3 months

Study Arms (2)

ARM 1 : MASK LED ALONE

EXPERIMENTAL

Participant aged between 40 and 55 years who presents signs of photodamage on the face as well as anti-aging signs (wrinkles, complexion, luminosity)

Device: MASK LED

ARM2 : DEVICE + COSMETIC FORMULA

ACTIVE COMPARATOR

Participant aged between 40 and 55 years who presents signs of photodamage on the face as well as anti-aging signs (wrinkles, complexion, luminosity)

Combination Product: LED MASK AND COSMETIC FORMULA

Interventions

MASK LED DEVICE

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

ARM 1 : MASK LED ALONE

LED MASK AND COSMETIC FORMULA COMBINATION_PRODUCT

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

ARM2 : DEVICE + COSMETIC FORMULA

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• L'Oreal: lead

Study Sites (1)

Eurofins CRL

Piscataway, New Jersey, 08854, United States

Location

Central Study Contacts

Audrey Natalizio, Clinical Project Manager

CONTACT

+ 33(0) 472 82 36 56; Audrey.Natalizio@cpt.eurofinseu.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)