NCT06140628

A 28-day Clinical Study on Facial Skin Rejuvenation

Clinical Study on 28 Day Continuous Improvement of Post-rejuvenation-treatment Skin With Formulations of A Proprietary Anti-aging Complex Composition

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Botanee Group Co., Ltd. · Industry
• Sex: Female
• Age: 30 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This clinical trial aims to learn about the efficacy of MLYAAT-1002® (a proprietary anti-aging complex, MLYAAT is short for "multi-layer anti-ageing technology" ) in female subjects who have newly received the rejuvenation treatment by comparing visual clinical scores, skin attributes measurement and image analysis.

Detailed description

The main expectation it aims to answer are: * After the 4-week continuous use of the test skin product with MLYAAT-1002®, the skin aging problem is significantly improved compared with it of controlled product. * After the single use of the test skin product with MLYAAT-1002®, the instant skin irritation after the Fotona4D Pro® treatment ( a nonablative fractional laser treatment for facial skin rejuvenation) is significantly lower compared with it of controlled product. * After the 4-week continuous use of the test skin product with MLYAAT-1002®, the skin TEWL (transepidermal water loss) is significantly recovered from the Fotona4D Pro® treatment compared with it of controlled product. And the skin TEWL after the 4-week continuous use of test product is improved or not significantly worse than it before the Fotona4D Pro® treatment. * After the 4-week continuous use of the test skin product with MLYAAT-1002®, no skin irritation symptom is worsen compared to it after the Fotona4D Pro® treatment.

Conditions

• Wrinkle
• Skin Laxity
• Skin Manifestations
• Skin

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Fotona4D Pro® treatment followed by daily use of formulations containing MLYAAT-1002®	Each subject will receive a single treatment of the Fotona4D Pro® , followed by the first application of the active comparator on the randomly assigned side of split-face (the treatment side) on the same day, and sequently, will apply the active comparator to this side twice a day for 28 days.
COMBINATION_PRODUCT	Fotona4D Pro® treatment followed by daily use of formulations without MLYAAT-1002®	Each subject will receive a single treatment of the Fotona4D Pro® , followed by the first application of the placebo comparator on the randomly assigned side of split-face (the control side) on the same day, and sequently, will apply the placebo comparator to this side twice a day for 28 dayd.

Timeline

• Start date: 2023-09-24
• Primary completion: 2023-11-07
• Completion: 2024-04-08
• First posted: 2023-11-20
• Last updated: 2024-08-16

Locations

1 site across 1 country: China