Pigmentation disorder, unspecified
Conditions
Interventions
A two-arm, double-blind, randomized controlled clinical trial. A total of 150 women with mild to moderate facial melasma, skin phototypes II to IV, who meet the eligibility criteria, will be randomly
B01.875.800.575.912.625.875.777
Sponsors
Divcom S/A
Medcin Instituto da Pele
Divcom S/A
Eligibility
Sex/Gender
Female
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Female participants; aged between 18 and 60 years; mild to moderate facial melasma; present phototype II to IV; no history of using cosmetic products with lightening action in the last 15 days or medications in the last 30 days
Exclusion criteria
Exclusion criteria: Pregnancy/ lactation; skin marks or dermatological conditions that interfere with the evaluation; atopic or allergic history to the product formula or sunscreen or products of the same category; medications that may impact skin pigmentation; active skin pathologies or lesions; immunosuppression due to drugs or active diseases; decompensated endocrinopathies; relevant clinical history of alcohol or drug abuse; intense sun exposure up to 15 days before; aesthetic or dermatological treatment up to 45 days before
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find an improvement of the melasma severity index, using the Modified Melasma Area and Severity Index scale conducted by a dermatologist on the facial region of participants. Data collected after 30, 60, 90, and 120 days of continuous use | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to observe an improvement in the melasma severity index, obtained through the modified Melasma Area and Severity Index (mMASI) scale, conducted by the dermatologist on the facial region of the participants at the beginning and end of the study;It is expected to observe the lightening action and evening out of facial skin tone through dermatological evaluations. Data collected after 30, 60, 90, and 120 days of continuous use;It is expected to observe the lightening efficacy of the investigational product in the treatment of melasma, through colorimetric analyses performed on the affected area and unaffected skin. Data collected after 60 and 120 days of continuous use;It is expected to observe an improvement in the firmness, elasticity, and viscosity of facial skin through cutometry measurements with the Cutometer device. Data collected after 60 and 120 days of continuous use;It is expected to observe an improvement in melasma through instrumental evaluations with confocal microscopy (MCR). Data collected after 60 and 120 days of continuous use;It is expected to observe the lightening and evening out of facial skin tone with the investigational product compared to the placebo, through dermatological evaluations, at the beginning and end of the study;It is expected to observe the depigmenting action of the investigational product compared to the placebo in the treatment of melasma, through colorimetric analyses performed on the affected area and unaffected skin, at the beginning and end of the study;It is expected to observe an improvement in facial skin firmness, elasticity, and viscosity through the use of the investigational product compared to the placebo, evaluated by cutometry measurements with the cutometer device at the beginning and end of the study | — |
Countries
Brazil
Contacts
Public ContactFernanda Bayan
Divcom S/A
Outcome results
None listed