Anti-pigmenting Effect of a Routine of Facial Products in Subjects With Melasma
NCT Number: NCT06516224
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Melasma
Interventions: OTHER: Liftactiv® B3 Serum|OTHER: Liftactiv® B3 retinol night cream|OTHER: Sunscreen UVAage® Inter SPF 50+|OTHER: Mineral 89 cream
Sponsor: Cosmetique Active International
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 150
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-15
Completion Date: 2025-01-31
Locations: CIDP, Rio de Janeiro, Brazil

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.

Primary Outcome Measures: antipigmenting assessment, Melasma Area Severity Index (MASI), Day 84|antipigmenting assessment, modified Melasma Area Severity Index (mMASI), Day 84|antipigmenting assessment, Melasma Area Severity Index(MASI), Day 168|antipigmenting assessment, modified Melasma Area Severity Index (mMASI), Day 168
Secondary Outcome Measures: antipigmenting assessment, Melasma Area Severity Index(MASI), Day-28|antipigmenting assessment, modified Melasma Area Severity Index (mMASI), Day-28|antipigmenting assessment, Melasma Area Severity Index(MASI), baseline|antipigmenting assessment, modified Melasma Area Severity Index (mMASI), baseline|antipigmenting assessment, Melasma Area Severity Index(MASI), Day 28|antipigmenting assessment, modified Melasma Area Severity Index (mMASI), Day 28|antipigmenting assessment, Melasma Area Severity Index(MASI), Day 56|antipigmenting assessment, modified Melasma Area Severity Index (mMASI), Day 56|antipigmenting assessment, Melasma Area Severity Index(MASI), Day 112|antipigmenting assessment, modified Melasma Area Severity Index (mMASI), Day 112|antipigmenting assessment, Melasma Area Severity Index(MASI), Day 140|antipigmenting assessment, modified Melasma Area Severity Index (mMASI), Day 140|Investigator Global Assessment (IGA) assessment, IGA score, Day -28|Investigator Global Assessment (IGA) assessment, IGA score, baseline|Investigator Global Assessment (IGA) assessment, IGA score, Day 28|Investigator Global Assessment (IGA) assessment, IGA score, Day 56|Investigator Global Assessment (IGA) assessment, IGA score, Day 84|Investigator Global Assessment (IGA) assessment, IGA score, Day 112|Investigator Global Assessment (IGA) assessment, IGA score, Day 140|Investigator Global Assessment (IGA) assessment, IGA score, Day 168|Clinical assessment (fine lines, skin tone, radiance, texture and elasticity), scores 0 to 5, Day -28|Clinical assessment (fine lines, skin tone, radiance, texture and elasticity), scores 0 to 5, baseline|Clinical assessment (fine lines, skin tone, radiance, texture and elasticity), scores 0 to 5, Day 28|Clinical assessment (fine lines, skin tone, radiance, texture and elasticity), scores 0 to 5, Day 84|Clinical assessment (fine lines, skin tone, radiance, texture and elasticity), scores 0 to 5, Day 168|Clinical scoring hyperpigmentation, scale 0 to 10, baseline|Clinical scoring hyperpigmentation, scale 0 to 10, Day 28|Clinical scoring hyperpigmentation, scale 0 to 10, Day 56|Clinical scoring hyperpigmentation, scale 0 to 10, Day 84|Clinical scoring hyperpigmentation, scale 0 to 10, Day 112|Clinical scoring hyperpigmentation, scale 0 to 10, Day 140|Clinical scoring hyperpigmentation, scale 0 to 10, Day 168|Clinical scoring target lesion comparing to surrounding skin, scale 0 to 10, baseline|Clinical scoring target lesion comparing to surrounding skin, scale 0 to 10, Day 28|Clinical scoring target lesion comparing to surrounding skin, scale 0 to 10, Day 56|Clinical scoring target lesion comparing to surrounding skin, scale 0 to 10, Day 84|Clinical scoring target lesion comparing to surrounding skin, scale 0 to 10, Day 112|Clinical scoring target lesion comparing to surrounding skin, scale 0 to 10, Day 140|Clinical scoring target lesion comparing to surrounding skin, scale 0 to 10, Day 168|Subject global efficay rating, rating, Day 28|Subject global efficay rating, rating, Day 56|Subject global efficay rating, rating, Day 84|Subject global efficay rating, rating, Day 112|Subject global efficay rating, rating, Day 140|Subject global efficay rating, rating, Day 168|Investigator global efficay rating, rating, Day 28|Investigator global efficay rating, rating, Day 56|Investigator global efficay rating, rating, Day 84|Investigator global efficay rating, rating, Day 112|Investigator global efficay rating, rating, Day 140|Investigator global efficay rating, rating, Day 168|Cosmetic acceptability, questionnaire, Day 28|Cosmetic acceptability, questionnaire, Day 56|Cosmetic acceptability, questionnaire, Day 84|Cosmetic acceptability, questionnaire, Day 112|Cosmetic acceptability, questionnaire, Day 140|Cosmetic acceptability, questionnaire, Day 168|Evolution of quality of life, MelasQoL, Day -28|Evolution of quality of life, MelasQoL, baseline|Evolution of quality of life, MelasQoL, Day 28|Evolution of quality of life, MelasQoL, Day 56|Evolution of quality of life, MelasQoL, Day 84|Evolution of quality of life, MelasQoL, Day 112|Evolution of quality of life, MelasQoL, Day 140|Evolution of quality of life, MelasQoL, Day 156|images, Standard facial pictures with Colorface® using standard 60, cross polarized, UV and no filters lights., baseline|images, Standard facial pictures with Colorface® using standard 60, cross polarized, UV and no filters lights., Day 28|images, Standard facial pictures with Colorface® using standard 60, cross polarized, UV and no filters lights., Day 56|images, Standard facial pictures with Colorface® using standard 60, cross polarized, UV and no filters lights., Day 84|images, Standard facial pictures with Colorface® using standard 60, cross polarized, UV and no filters lights., Day 112|images, Standard facial pictures with Colorface® using standard 60, cross polarized, UV and no filters lights., Day 140|images, Standard facial pictures with Colorface® using standard 60, cross polarized, UV and no filters lights., Day 168|Skin quality, Chromameter, Individual Typology Angle (ITA), baseline|Skin quality, Chromameter, Individual Typology Angle (ITA), Day 28|Skin quality, Chromameter, Individual Typology Angle (ITA), Day 56|Skin quality, Chromameter, Individual Typology Angle (ITA), Day 84|Skin quality, Chromameter, Individual Typology Angle (ITA), Day 112|Skin quality, Chromameter, Individual Typology Angle (ITA), Day 140|Skin quality, Chromameter, Individual Typology Angle (ITA), Day 168|transepidermal water loss, Tewameter, baseline|transepidermal water loss, Tewameter, Day 28|transepidermal water loss, Tewameter, Day 56|transepidermal water loss, Tewameter, Day 84|transepidermal water loss, Tewameter, Day 112|transepidermal water loss, Tewameter, Day 140|transepidermal water loss, Tewameter, Day 168|skin hydration, Corneometer, baseline|skin hydration, Corneometer, Day 28|skin hydration, Corneometer, Day 56|skin hydration, Corneometer, Day 84|skin hydration, Corneometer, Day 112|skin hydration, Corneometer, Day 140|skin hydration, Corneometer, Day 168|confocal, confocal measurements (15 subjects), baseline|confocal, confocal measurements (15 subjects), Day 84|confocal, confocal measurements (15 subjects), Day 168|exposome questionnaire, questionnaire, baseline|Melasma status, questionnaire, baseline|adverse events, reporting, baseline|adverse events, reporting, Day 28|adverse events, reporting, Day 56|adverse events, reporting, Day 84|adverse events, reporting, Day 112|adverse events, reporting, Day 140|adverse events, reporting, Day 168