Health TrialsbyHealthPanel

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

ConditionsPhotodamage of the FaceAnti Aging
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age35-60
SponsorL'Oreal

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Female subjects aged between 35-60y.o

Presenting all skin types

Presenting all phototype according to Fitzpatrick Classification

Sensitive skin (50%) - declarative

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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

  • 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

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: ARM 1 : MASK LED ALONEExperimental treatment 1 intervention
Group B: ARM2 : DEVICE + COSMETIC FORMULAActive comparator 1 intervention

Trial outcomes

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)

Time frame
baseline to 3 months

Secondary outcomes

1

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

Time frame
Immediate time to 3 months
2

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)

Time frame
immediat time to 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

L'Oreal

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: