To assess the efficacy of the Epilady investigational device, used with and without a topical depigmenting formula, in reducing the appearance of lentigo spots on the hands and forearms of healthy female participants over an 84-day period
Healthy female participants aged between 35 and 70 years old at the time of inclusion.
All Fitzpatrick skin phototypes (I to VI) are eligible; groups I-II and V-VI should include at least one participant per group.
Presence of at least two solar lentigo (dark spots) on each hand or forearm, with each spot measuring less than 100 mm x 100 mm as assessed by the investigator.
Participant has read, understood, and accepted the constraints of the clinical investigation.
• Participants with dry or sensitive skin, as assessed by the investigator.
Participants who have used cosmetic products with exfoliating or astringent claims on the hands within 4 weeks prior to the baseline visit.
Participants who have used any home-use or professional low-level laser therapy (LLLT) or have participated in clinical studies involving LLLT within the 6 months preceding the baseline visit
History of light-induced seizures or chronic migraine disorders.
Parallel
LASER
Other interventionApplication of laser once a weeks by dermatologist on spot and application of sunscreen twice a day ( morning and midday) for 3 months
LASER AND ACTIVE FORMULA
Combination productapplication of laser once a week by dermatologist, active formula twice a day ( morning and evening) and sunscreen formula twice a day (morning and midday) for 3 months
Change of the pigmentation intensity of solar lentigo
The investigator will perform a standardized clinical evaluation of the targeted lentigo lesions, grading pigmentation intensity using a standardized Color Chart (2021-EV-FR-ICE-Color Chart Procedure, see figure 2) to assess the darkness of each lentigo lesion compared to the surrounding skin.
Global tolerance
The investigator will assign an overall tolerance score for the treatment area at each visit using the following scale 1: very good ; 2: good; 3: Moderate; 4: Bad
Lentigines Global Improvement Scale (LGIS)
The investigator will assess the overall improvement of each treatment area using the Lentigines Global Improvement Scale (LGIS). This scale rates changes in pigmentation, lesion size, and skin homogeneity with 7 grades ( 0 : Completrely clear to 6 : worse)
Self assessment questionnaire
Participants 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, comfort during and after use, perceived reduction in pigmentation , improvement in overall skin appearance (tone, brightness, clarity), and overall satisfaction
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