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NOT YET RECRUITING
NCT06891924
NA

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

Sponsor: Botanee Group Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

35 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2025-03-25

Completion Date

2025-06-01

Last Updated

2025-04-01

Healthy Volunteers

Yes

Interventions

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.