NCT06891924

A Clinical Study on Pre-operative Intervention With Products During Aesthetic Medicine

Clinical Study on Pre-operative Intervention With Products to Mitigate Skin Discomfort During Aesthetic Medicine

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (estimated)
• Sponsor: Botanee Group Co., Ltd. · Industry
• Sex: Female
• Age: 35 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This clinical trial aims to evaluate whether a 14-day pre-operative application of the test product (containing MLYAAT-1002®, a proprietary anti-aging complex) can mitigate skin discomfort during Fotona 4D laser therapy (Frac3 and Piano modes) by comparing clinical evaluation, skin attributes measurement and subject self-assessment.

Conditions

• Skin Aging
• Skin Condition
• Skin Manifestations

Interventions

Type	Name	Description
COMBINATION_PRODUCT	14-day daily pre-operative application of the formulations containing MLYAAT-1002® before Fotona4D treatment	All enrolled subjects will complete a 14-day washout period followed by a 14-day run-in phase prior to Fotona 4D® laser treatment. During the initial washout phase, participants will exclusively use basic skincare products: sunscreen, cleansing foam, and moisturizing emulsion. Then the subjects will apply the formulations containing MLYAAT-1002® of the active comparator to randomly assigned split-face (the treatment side) for the subsequent 14-day period. Following completion of the product application regimen, all participants will undergo a single session of Fotona 4D laser therapy.
COMBINATION_PRODUCT	14-day daily pre-operative application of the formulations without MLYAAT-1002® before Fotona4D treatment	All enrolled subjects will complete a 14-day washout period followed by a 14-day run-in phase prior to Fotona 4D® laser treatment. During the initial washout phase, participants will exclusively use basic skincare products: sunscreen, cleansing foam, and moisturizing emulsion. Then the subjects will apply the formulations without MLYAAT-1002® of the placebo comparator to randomly assigned split-face (the control side) for the subsequent 14-day period. Following completion of the product application regimen, all participants will undergo a single session of Fotona 4D laser therapy.

Timeline

• Start date: 2025-03-25
• Primary completion: 2025-06-01
• Completion: 2025-06-01
• First posted: 2025-03-24
• Last updated: 2025-04-01