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

NCT06891924 | Not Yet Recruiting

• 1 other identifier: Botanee-252003
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• changes in transepidermal water loss (TEWL) of facial skin

  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

  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)

Study Arms (2)

Formulation containing MLYAAT-1002® Composition

ACTIVE COMPARATOR

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

Blank formulation without MLYAAT-1002® Composition

PLACEBO COMPARATOR

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

Interventions

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

Formulation containing MLYAAT-1002® Composition

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

Blank formulation without MLYAAT-1002® Composition

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Botanee Group Co., Ltd.: lead

MeSH Terms

Conditions

Skin Diseases; Skin Manifestations

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yihuai Liang

CONTACT

+86 13818831247; liangyihuai@botanee.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 24, 2025
• Study Start: March 25, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share