Photodamage of the FaceNCT07661004
Evaluation of the Efficacy and Tolerability of the LED Mask With or Without the Serum Formula on the Signs of Facial Photodamage .
A study testing MASK LED and LED MASK AND COSMETIC FORMULA in people with Photodamage of the Face and Anti Aging, run by L'Oreal at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 35 to 60 years, women only
- Conditions the study is for
- Photodamage of the Face, Anti Aging
- What is being tested?
- MASK LED and LED MASK AND COSMETIC FORMULA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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,
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- 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)
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Audrey Natalizio, Clinical Project Manager contact
About this study
Official title: 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
Read the detailed description
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.
- Conditions
- Photodamage of the Face, Anti Aging
- Being tested
- MASK LED, LED MASK AND COSMETIC FORMULA
- Keywords
- WRINKLES, SAFETY, EFFICACY, MASK LED, CONSUMER PERCEPTION
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MASK LEDDevice
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
LED MASK AND COSMETIC FORMULACombination 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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: Combination Product: LED MASK AND COSMETIC FORMULA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: baseline to 3 months
Secondary outcomes (2)
Global tolerance
The investigator will assign an overall tolerance score at each visit using the following scale 1: very good ; 2: good ; 3: Moderate ; 4 : Bad
Measured: Immediate time to 3 months
Self assessment questionnaire
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)
Measured: immediat time to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Photodamage of the FaceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- L'Oreal
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661004
- Sponsor's protocol ID
- EV 2512-1248 MASK LED
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data confidentiality, not provided for in the consent to participation, application of the GDPR
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Tolerability of the LED Mask With or Without the Serum Formula on the Signs of Facial Photodamage
- ClinicalTrials.gov ID
- NCT07661004
- Acronym / sponsor ID
- EV 2512-1248 MASK LED
- Conditions
- Photodamage of the Face, Anti Aging
- Keywords
- WRINKLES, SAFETY, EFFICACY, MASK LED, CONSUMER PERCEPTION
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- L'OrealIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARM 1 : MASK LED ALONE | Experimental | Device: MASK LEDParticipant aged between 40 and 55 years who presents signs of photodamage on the face as well as anti-aging signs (wrinkles, complexion, luminosity) |
| ARM2 : DEVICE + COSMETIC FORMULA | Active comparator | Combination Product: LED MASK AND COSMETIC FORMULAParticipant aged between 40 and 55 years who presents signs of photodamage on the face as well as anti-aging signs (wrinkles, complexion, luminosity) |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MASK LEDApplication 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 | Device | ARM 1 : MASK LED ALONE |
| LED MASK AND COSMETIC FORMULAapplication 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 | Combination product | ARM2 : DEVICE + COSMETIC FORMULA |
Primary outcome
Improvement of anti-aging parameters
Time frame: 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)
2 secondary outcomes
Global tolerance
Time frame: Immediate time to 3 months
Self assessment questionnaire
Time frame: immediat time to 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No. Data confidentiality, not provided for in the consent to participation, application of the GDPR
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Audrey Natalizio, Clinical Project Manager contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MASK LED and LED MASK AND COSMETIC FORMULA in people with Photodamage of the Face and Anti Aging, run by L'Oreal at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Audrey Natalizio, Clinical Project Manager (+ 33(0) 472 82 36 56, Audrey.Natalizio@cpt.eurofinseu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of anti-aging parameters (time frame: baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.