Anti-pigmenting Effect of a Routine of Facial Products in Subjects With Melasma

Cosmetique Active International150 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

Melasma

Interventions

Liftactiv® B3 SerumOTHER

In Group 1: Application once daily for 6 months, 3-4 drops twice a day (morning before the sunscreen and evening) In Group 2 and Group 3: Application once daily, 3-4 drops twice a day (morning before the sunscreen and evening) for 3 months following HQ4% or Kligman Trio treatment.

Liftactiv® B3 retinol night creamOTHER

In Group 1: Application once daily (morning) for 6 months In Group 2 and Group 3: During week 1, apply 2 evenings/week. During week 2, apply every other evening. During week 3, apply every evening. During nights when retinol night cream is not applied, replace with Mineral 89 cream for 3 months following HQ4% or Kligman Trio treatment.

Sunscreen UVAage® Inter SPF 50+OTHER

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

CIDP

Rio de Janeiro, Brazil

Outcomes

Primary Outcomes

antipigmenting assessment

Melasma Area Severity Index (MASI)

Time frame: Day 84

antipigmenting assessment

modified Melasma Area Severity Index (mMASI)

Time frame: Day 84

antipigmenting assessment

Melasma Area Severity Index(MASI)

Time frame: Day 168

antipigmenting assessment

modified Melasma Area Severity Index (mMASI)

Time frame: Day 168

Secondary Outcomes

antipigmenting assessment

Melasma Area Severity Index(MASI)

Time frame: Day-28

antipigmenting assessment

modified Melasma Area Severity Index (mMASI)

Time frame: Day-28

antipigmenting assessment

Melasma Area Severity Index(MASI)

Time frame: baseline

antipigmenting assessment

modified Melasma Area Severity Index (mMASI)

Time frame: baseline

antipigmenting assessment

Melasma Area Severity Index(MASI)

Time frame: Day 28

antipigmenting assessment

Central Contacts

Claire Deloche-Bensmain, PhD

CONTACT

+33 7 76 11 27 98 claire.deloche-bensmaine@loreal.com

Marianna Feiges

CONTACT

mariana.feiges@loreal.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.