Dark spot Skin and Connective Tissue Diseases
Conditions
Interventions
Laser treatment with or without formula.
This study is an intra-individual randomized right/left study.
The right or left side will receive on-site laser treatment once a week for 3 months.
The other
Sponsors
L'Oréal (France)
Eligibility
Sex/Gender
Female
Age
35 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Healthy female participants aged between 35 and 70 years old at the time of inclusion. 2. All Fitzpatrick skin phototypes (I to VI) are eligible; groups I-II and V-VI should include at least one participant per group. 3. 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. 4. Participant has read, understood, and accepted the constraints of the clinical investigation. 5. Participant has provided written informed consent to participate in the clinical investigation 6. Participant is able to understand the language used in the investigational site and comprehend the information provided. 7. Participants are cooperative and compliant, aware of the clinical investigation requirements and willing to adhere to the full duration of participation and follow-up visits, in line with the CIP requirements. 8. Women of childbearing potential must commit to using an effective contraceptive method throughout the clinical investigation period and for at least three months prior to the inclusion visit, with no changes during that time.
Exclusion criteria
Exclusion criteria: 1. Participants with dry or sensitive skin, as assessed by the investigator. 2. Participants who have used cosmetic products with exfoliating or astringent claims on the hands within 4 weeks prior to the baseline visit. 3. 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. 4. History of light-induced seizures or chronic migraine disorders. 5. History of photosensitivity or photoallergic reactions. 6. Presence of underlying dermatological conditions on the hands/forearms that, in the opinion of the investigator, could interfere with the clinical investigation assessments. 7. History of keloid scar formation. 8. A family history of melanoma in first- or second-degree relatives (parents or grandparents). 9. Presence of excessive moles, non-lentigo pigmented lesions, tattoos, scars, or irritated skin in the test area that could affect the validity of the investigation. 10. History of surgical procedures involving the areas designated for treatment. 11. Participants who have been exposed to or plan to be exposed to sunbathing or artificial UV sources (e.g., mountain sports, phototherapy, tanning salons) within 1 month before the clinical investigation start or during the clinical investigation period. 12. Use of suntan or self-tanning products within the 2 weeks preceding the baseline visit. 13. Change in cosmetic habits (e.g., moisturizers, skincare, shower gels) during the 2 weeks prior to baseline. 14. Use of any medications, topical treatments, skincare products, or aesthetic procedures listed in the CIP without observing the required wash-out periods, or unwillingness/inability to comply with those restrictions during the clinical investigation. 15. Participant who cannot be contacted by telephone in case of emergency. 16. Participant in an exclusion period or participating in another biomedical research clinical investigation (self-reported). 17. Intellectual/mental inability to follow clinical investigation instructions (if suspected) or incapacitation. 18. Participants working for the contract research organization (CIDP) in charge of this clinical investigation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pigmentation intensity of lentigo spots as assessed by a clinical color chart (e.g., L’Oréal pigmentation scale) at baseline , D28, D56 an D84 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Lentigines Global Improvement Scale (LGIS) score ( 0 : Completery clear to 6: worse) at D28, D56 an D84 2. Participant self-assessment of efficacy as assessed by questionnaire t baseline , D28, D56 an D84 3. Investigators assessed local tolerance (erythema, edema, dryness, etc.) at D0 (before treatment) and after each application of the device 4. Global tolerance as assess by investigator by the scale with 4 grades ( 1: very good to 4 :bad) at D28, D56 an D84 5. Assessment of all adverse events (AEs) and serious adverse events (SAEs) occurring during the clinical investigation to determine device-relatedness and severity, serving as a safety endpoint for the entire duration of the study | — |
Countries
Mauritius
Contacts
Public ContactGitanjali Petkar
Outcome results
None listed