NCT06516224

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Cosmetique Active International · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Melasma

Interventions

Type	Name	Description
OTHER	Liftactiv® B3 Serum	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.
OTHER	Liftactiv® B3 retinol night cream	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.
OTHER	Sunscreen UVAage® Inter SPF 50+	twice daily (morning and beginning of the afternoon)
OTHER	Mineral 89 cream	2 drops in the morning before sunscreen application for 6 months

Timeline

• Start date: 2024-07-15
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2024-07-23
• Last updated: 2024-07-23

Locations

1 site across 1 country: Brazil