This 6 month, comparative study assesses the benefit of a dermocosmetic regimen (Serum B3 + B3 retinol night cream) for 6 months compared to hydroquinone 4% (the gold standard in hyperpigmentation) followed by the dermocosmetic regimen for 3 months or the Kligman Trio for 3 months followed by the dermocosmetic regimen for 3 months in adult women with melasma on the face.

Study objective

1. Assessing the antipigmenting efficacy of the routine (serum B3 + B3 retinol night cream) in women with melasma.
2. Evaluation of Kligman Trio (KT) (Vitacid Plus) compared to the routine (serum B3 + B3 retinol night cream)
3. Evaluation of Hydroquinone 4% (HQ 4%) compared to the routine (serum B3 + B3 retinol night cream).
4. Assessment of the routine maintenance with SERUM B3 + retinol B3 night cream after 3 months of use of Klingman Trio (KT)(Vitacid plus) and HQ4%

Primary endpoint:

o Improvement of mMASI and MASI

Secondary endpoints:

• Improvement of Physician Global Assessment IGA for melasma
• Improvements on clinical parameters such as fine lines, skin tone, radiance, skin texture and skin elasticity evaluated by the investigator.
• Global efficacy by the subject and by the investigator (Physician's Global assessment)
• Global tolerance
• Safety
• Cosmetic acceptability
• Improvement of Quality of life (MelasQOL)
• Exposome questionnaire
• Questionnaire on hormonal status
• Improvement of the morphological and structural characteristics of ageing skin - By confocal microscopy (15 subjects per subgroup)
• Clinical scoring: hyperpigmentation scale
• Standard facial pictures with Colorface®
• Chromameter® measurements (target lesion assessment compared to non lesional surrounding skin)
• Tewameter® measurements
• Corneometer® measurements

Inclusion Criteria:

• 18-65 years
• Phototype II-V
• 50% with sensitive skin (declarative);
• Subjects should be affected by well defined symmetrical (on both sides of the face) epidermal melasma (clinically diagnosed under Wood's light examination) lasting since more than a year

Exclusion Criteria:

• Subjects under topical or systemic retinoids;
• Subjects having used topical tretinoin within 3 months or topical hydroquinone within 6 months prior to inclusion;
• Subjects under systemic immunosuppressants and considered immune compromised
• Subjects under active treatment of melasma (including topicals or procedures) within the last 3 months
• Pregnant women and/or breastfeeding women
• Subjects with a recent change in contraception (since less than 6 months);
• Subjects known allergy to any component of tested product;
• Subjects not presenting with the conditions needed to comply with the protocol;
• Subjects without any other dermatological conditions on the face
• Subject under menopause phase with hormonal replace therapy
• Subjects in the initial phase, change or discontinuation of hormonal treatment (estroprogesterone, cyproteron acetate, androgenic...) in the last 3 months;
• Subjects currently using any medication, which in the opinion of the investigator, may affect the evaluation of the study product, or place the subject at undue risk.
• Subjects unable to give their informed consent.

the protocol will be shared by the sponsor upon reasonable request for one year after the end of the study

one after finishing study

upon request to the sponsor

Subjects will be randomized in three groups and will be treated differently taking into account only the original Melasma Area Severity Index (MASI) score at baseline:

• An adaptive randomization scheme (minimization method) will be used to determine the treatment group (among the 3 available) to which eligible subjects will be enrolled in. This strategy will ensure a balance between treatment groups for one important prognostic factor, identified as 'baseline MASI'. When a new subject is eligible for randomization, the algorithm verifies the average MASI of the subjects in each group. The new subject will be allocated to a group in such a way that the imbalance is minimized among the groups.