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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Skin Manifestations; Skin Condition; Skin Aging
• Intervention / Treatment: Combination product: 14-day daily pre-operative application of the formulations containing MLYAAT-1002® before Fotona4D treatment; Combination product: 14-day daily pre-operative application of the formulations without MLYAAT-1002® before Fotona4D treatment

• Study Type: Interventional
• Enrollment (Estimated): 33
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yihuai Liang; Phone Number: +86 13818831247; Email: liangyihuai@botanee.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• health females aged 35-60;
• subjects with rough dark, loose fine lines;
• no history of cosmetic allergies;
• subjects are willing to use the test serum on split-face for 28 days;
• subjects are willing to suffer the Fotona 4D treatment (Frac3 and Piano modes) on the face;
• subjects are willing to use the basic skincare products for 28 days, and acceptable for split-face use of the test products or the control product for 14 days;
• written informed consent and portrait right consent were obtained from all participants before study entry.

Exclusion Criteria:

• anyone who is pregnant, nursing an infant, or planning a pregnancy during the study;
• subjects with known allergies or sensitivities to the ingredients in any of the study products;
• 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, and dermal fillers within one month;
• taken/injected anti-allergy medication in the past one month;
• participants in other clinical trials at the same time;
• any subjects that the investigator considers ineligible.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Formulation containing MLYAAT-1002® Composition; Before the Fotana4D Pro® treatment, daily use of the formulation containing MLYAAT-1002® for 14 days: apply one pump of the formulation to the test side of the face twice daily.	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.
Placebo Comparator: Blank formulation without MLYAAT-1002® Composition; Before the Fotana4D Pro® treatment, daily use of the formulation without MLYAAT-1002® for 14 days: apply one pump of the formulation to the control side of the face twice daily.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in the percentage of area in the red zone of facial skin	capturing facial images by VISIA-CR (CANFIELD, America) and analysis the percentage of area in the red zone.	Baseline (before Fotona 4D treatment), T30min (30 minutes after Fotona 4D treatment), T2h (2 hours after Fotona 4D treatment)
Self-assessment of the facial state questionnaire	Subjects rated the burning sensation, picotement, pruritus, dysesthesia, tightness,on a five-point scale: 0=Asymptomatic;1=Very mild;2=mild;3=moderate;4=severe	Baseline (before Fotona 4D treatment), Timm (immediately after Fotona 4D treatment), T30min (30 minutes after Fotona 4D treatment), T2h (2 hours after Fotona 4D treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in transepidermal water loss (TEWL) of facial skin	measuring the loss of water that passes from inside a body through the epidermis to the surrounding atmosphere by Vapometer.	D-14(14 days before Fotona 4D treatment), Baseline (before Fotona 4D treatment), T30min (30 minutes after Fotona 4D treatment), T2h (2 hours after Fotona 4D treatment)
changes in skin stratum corneum water content	measuring skin stratum corneum water content by Corneometer CM825 (Courage&Khazaka，Germany).	D-14(14 days before Fotona 4D treatment), Baseline (before Fotona 4D treatment), T30min (30 minutes after Fotona 4D treatment), T2h (2 hours after Fotona 4D treatment)

Collaborators and Investigators

• Sponsor: Botanee Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): March 25, 2025
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: March 18, 2025
• First Submitted That Met QC Criteria: March 18, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): April 1, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Manifestations
• Other Study ID Numbers: Botanee-252003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No