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

NCT ID: NCT06891924

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-25
• Study Completion Date: 2025-06-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

14-day daily pre-operative application of the formulations containing MLYAAT-1002® before Fotona4D treatment

Intervention Type: COMBINATION_PRODUCT

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.

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.

Group Type: PLACEBO_COMPARATOR

14-day daily pre-operative application of the formulations without MLYAAT-1002® before Fotona4D treatment

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Botanee Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Yihuai Liang

Role: CONTACT

liangyihuai@botanee.com

+86 13818831247

Other Identifiers

Botanee-252003

Identifier Type: -

Identifier Source: org_study_id