An observational study in Skin Pigmentation, Healthy Volunteers and Hyperpigmentation, sponsored by Cosmetique Active International. Completed at 1 site in Romania. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-17.
Sponsored by Cosmetique Active International (part of L'Oréal) · Observational
The goal of this double-blind, randomized clinical trial is to evaluate the efficacy of anti-pigmentation cosmetic products in preventing skin pigmentation induced by High Energy Visible Light (HEVL) [400-450nm] in healthy volunteers (male and female, aged 18-60 years, Caucasian, phototypes III-IV).
The main questions it aims to answer are:
Can anti-pigmentation agents and/or HEV filters reduce HEV light-induced skin pigmentation, as measured by the Individual Typological Angle (Delta ITA°)? Can these products improve additional colorimetric parameters (Delta L*, a*, b*, Delta E) and clinical pigmentation and erythema scores (0-13 scale)? Are these formulations safe and well-tolerated under HEVL exposure? Researchers will compare seven cosmetic formulations (Products A to G) to an untreated exposed control zone to assess their ability to prevent HEVL-induced pigmentation.
Participants will:
Attend 36 visits over 7 weeks Receive standardized product applications (2 mg/cm²) on 7 test zones (3x3 cm) delineated on their back. One test zone will be not treated.
Be exposed to HEVL light [400-450nm] at 35 J/cm² over 4 consecutive days (Days 8-11) Undergo colorimetric measurements and clinical assessments of pigmentation and erythema at 13 time points
127 studies on the registry are indexed under Hyperpigmentation; 28 are open to participants now.
This study's enrollment of 33 is below the median of 100 across 12 observational studies indexed under Hyperpigmentation.
Browse Hyperpigmentation studies →Cosmetique Active International is the lead sponsor of 55 studies on the registry; 13 are open to participants now.
Compared within Hyperpigmentation, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pigmentation Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Healthy male and female volunteers from 18 to 60 yo, with Fitzpatrick III and IV and an ITA° between 18° to 35° at screening.
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:
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.
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.
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.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
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.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47
Other: Treated and exposed zones (cosmetic topical products applied)
Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47
Other: Treated and exposed zones (cosmetic topical products applied)
Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47
Other: Treated and exposed zones (cosmetic topical products applied)
Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47
Other: Treated and exposed zones (cosmetic topical products applied)
Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47
Other: Treated and exposed zones (cosmetic topical products applied)
Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47
Other: Treated and exposed zones (cosmetic topical products applied)
Topical cosmetic emulsion applied at 2 mg/cm² on a 3x3 cm zone of the back according to the randomization list from Day 1 to Day 47
Other: Treated and exposed zones (cosmetic topical products applied)
non treated zone
Other: Untreated and exposed zone (no product applied)
exposed to HEVL source to induce skin pigmentation (35 J/cm²) during 4 consecutive days (from Day 8 to Day 11)
exposed to HEVL source to induce skin pigmentation (35 J/cm²) during 4 consecutive days (from Day 8 to Day 11)
Skin color measurement
Measurement of the skin color using Chromameter® (non-invasive assessment) between the exposed zone (ZE) and the adjacent non-exposed zone (ZNE).
Time frame: From Day 1 to Day 47
Visual scoring of pigmentation
Visual evaluation of the pigmentation using L'Oreal pigmentation scale (0-13 points)
Time frame: From Day 1 to Day 47
Visual scoring of erythema
Visual evaluation of the erythema using L'Oreal erythema scale (0-13 points)
Time frame: From Day 1 to Day 47
Incidence of Emergent Adverse Events [Tolerability included]
Safety will be assessed by recording Adverse Events, including cutaneous reactions (local intolerance), from the informed consent form signature date until the end of the study.
Time frame: From Day 1 to Day 47
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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