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

Botanee Group Co., Ltd.1 个研究点分布在 1 个国家目标入组 37 人开始时间: 2023年9月24日最近更新: 2024年8月16日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 37
试验地点: 1
主要终点: changes in elasticity of facial skin (F4)

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Outcomes Assessor)

入排标准

年龄范围: 30 Years 至 50 Years（Adult）
性别: Female
接受健康志愿者: 是

入选标准

•females aged 30-50
•no history of cosmetic allergies
•according to SKIN AGING ATLAS 2(Asian Type), the scores of under-eye wrinkles, pore appearance, forehead wrinkles are all > 2
•non-sensitive skin
•acceptable for split-face use of products for 28 days
•no using history of antibiotic in the past three months
•written informed consent and portrait right consent were obtained from all participants before study entry

排除标准

•subjects with known allergies or sensitivities to the ingredients in any of the study products
•anyone who is pregnant, nursing an infant, or planning a pregnancy during the study
•any symptoms of facial flushing, erythema, papules, desquamation, or edema as evaluated by a physician prior to initial screening or Fotona4D Pro treatment
•unhealed skin lesions
•participated in any other clinical trial within one month
•received facial skin treatments including but not limited to lasers, chemical peels, dermal fillers within one year
•taken/injected anti-allergy medication in the past one month
•other medical reasons that could affect the test results
•participants in other clinical trials at the same time