anti-pigmenting effect of a routine of facial products in subjects with melasma

Conditions: Melasma

Summary: 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

Eligibility criteria:
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.

Keywords: melasma hyperpigmentation