An interventional study of LASER and LASER AND ACTIVE FORMULA in Solar Lentigo, sponsored by Cosmetique Active International. Not yet recruiting at 1 site in Mauritius. Open to female participants aged 35 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-20.
Sponsored by Cosmetique Active International (part of L'Oréal) · Not applicable, Interventional, and Treatment
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
Rational The investigational product in this clinical investigation, the Epilady laser-based device, applies the principle of selective photothermolysis to target melanin within pigmented lesions. It uses diode laser technology at either 660 nm or 808 nm, selected according to the participant's skin phototype, and is equipped with a camera-guided targeting system and integrated safety sensors for precise and controlled energy delivery. The device has been classified as a Class IIb medical device in the EU, intended for the permanent reduction of pigmentation such as lentigines.
Design:
This is a prospective, open-label, randomized, intra-individual controlled clinical investigation conducted in healthy female participants aged 35 to 70 years. The clinical investigation is designed to evaluate the efficacy and safety of the Epilady prototype laser medical device, used alone or in combination with a cosmetic depigmenting formula, in reducing the pigmentation of lentigo spots on the hands and lower forearms.
Following inclusion, the left and right hands (or forearms) of each participant will be randomized:
Reglementation The clinical investigation will be conducted in compliance with Good Clinical Practice (GCP) guidelines and applicable regulatory requirements for medical device investigations, ISO 14155.
Objectifs \& Statistiques Safety analyses will be performed on the SS population, while efficacy analyses will be primarily performed on the ITT population. If the sample size between the PP and ITT populations differs by more than 10%, the efficacy analysis will also be performed on the PP population.
Pigmentation intensity by L'Oréal color chart:
The score of the "balance of red/yellow" will be coded as follows:
The change in red/yellow component [letters G (red tendency) to M (yellow tendency)] will be added to the change in lightness [numbers 19 (dark skin) to 5 (fair skin)] for analysis purposes, e.g. a change from G18 to J15 will correspond to a change of -6 units.
On each assessed area separately (lentigo spot and adjacent) and each side, the significance of the change from baseline will be assessed using a one sample t-test (versus 0, which would indicate no change).
The assessment of the change from baseline on each side will be assessed using a Paired Samples t-test or the Wilcoxon Signed Ranked, depending on the normality of the data. Similarly, the comparison of the two sides will be assessed using the same statistical tests. The normality of the data will be tested at 1% of the Shapiro Wilk test.
Lentigines Global Improvement Scale (LGIS):
At each visit, the comparison of the two treatments will be investigated using a Wilcoxon Signed Rank test.
Self-assessment efficacy questionnaires:
The answers to the efficacy questionnaire will be summarized in a frequency table by category, together with 100% stacked bar charts.
Safety assessment:
AEs will be listed by participants including time of onset, time from the first administration of clinical investigation drug, duration, intensity, action taken, corrective therapies, outcome, relationship to clinical investigation drug and seriousness.
Local tolerance will be reported descriptively.
For the comparison of treatments, the null and alternative hypotheses are as follows:
H0: There is no difference between the two treatments H1: There is difference between the two treatments To claim superiority of the device + cosmetic formula, the null hypothesis should be rejected, and the average score should be in favor of the device + cosmetic formula.
Significance level :The null hypothesis will generally be rejected if a p-value less than 0.05 (5% significance level) is produced by the statistical procedure.
28 studies on the registry are indexed under Lentigo; 2 are open to participants now.
This study's planned enrollment of 44 is above the median of 30 across 25 interventional studies indexed under Lentigo.
Browse Lentigo studies →Cosmetique Active International is the lead sponsor of 55 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants with dry or sensitive skin, as assessed by the investigator.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy participants aged between 35 and 70 years old with presence of at least two solar lentigo on each hand or forearm, with each spot measuring less than 100 mm x 100 mm as assessed by the investigator
Other: LASER
Healthy participants aged between 35 and 70 years old with presence of at least two solar lentigo on each hand or forearm, with each spot measuring less than 100 mm x 100 mm as assessed by the investigator
Combination Product: LASER AND ACTIVE FORMULA
Application of laser once a weeks by dermatologist on spot and application of sunscreen twice a day ( morning and midday) for 3 months
application 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.
Time frame: baseline to 3 months
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
Time frame: 1 month to 3 months
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)
Time frame: baseline to 3 months
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
Time frame: 3 months
Start is estimated for Jan 2026; primary completion for May 2026, 4 months later.
Of 11 interventional studies with no phase under Lentigo, half reached primary completion within 2 months of starting (the median); a quarter within 1 and three quarters within 13. This study's planned 4 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Cosmetique Active International →