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

Cosmetique Active

Status: Not yet enrolling

Conditions: Melasma

Treatments: Other: Sunscreen UVAage® Inter SPF 50+; Other: Mineral 89 cream; Other: Liftactiv® B3 retinol night cream; Other: Liftactiv® B3 Serum

Study type: Interventional

Funder types: Industry

Identifiers

NCT06516224

VCY23-001

Details and patient eligibility

About

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.

Full description

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

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups

Group 1

Experimental group

Description:

dermocosmetic regimen consisting in Liftactiv(® B3 serum + Liftactiv® B3 retinol night cream (all Vichy Laboratoires, France) for 6 months + Mineral 89 cream + Sunscreen UVAage Inter SPF 50+

Treatment:

Other: Liftactiv® B3 Serum

Other: Liftactiv® B3 retinol night cream

Other: Mineral 89 cream

Other: Sunscreen UVAage® Inter SPF 50+

Group 2

Active Comparator group

Description:

hydroquinone 4% (HQ4%, Hydroquinona 40 mg/g, Germed, Brazil) for 3 months followed by the dermocosmetic regimen (Liftactiv(® B3 serum + Liftactiv® B3 retinol night cream + Mineral 89 cream + Sunscreen UVAage Inter SPF 50+) for 3 months

Treatment:

Other: Liftactiv® B3 Serum

Other: Liftactiv® B3 retinol night cream

Other: Mineral 89 cream

Other: Sunscreen UVAage® Inter SPF 50+

Group 3

Active Comparator group

Description:

Combination of hydroquinone, resorcinol corticosteroid (Kligman Trio, Vitacid Plus Cream, Claredor Brazil) for 3 months followed by the dermocosmetic regimen (Liftactiv(® B3 serum + Liftactiv® B3 retinol night cream + Mineral 89 cream + Sunscreen UVAage Inter SPF 50+) for 3 months

Treatment:

Other: Liftactiv® B3 Serum

Other: Liftactiv® B3 retinol night cream

Other: Mineral 89 cream

Other: Sunscreen UVAage® Inter SPF 50+