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

Botanee Group

Status: Not yet enrolling

Conditions: Skin Manifestations; Skin Condition; Skin Aging

Treatments: Combination Product: 14-day daily pre-operative application of the formulations without MLYAAT-1002® before Fotona4D treatment; Combination Product: 14-day daily pre-operative application of the formulations containing MLYAAT-1002® before Fotona4D treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT06891924

Botanee-252003

Details and patient eligibility

About

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.

Enrollment: 33 estimated patients

Sex: Female

Ages: 35 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

33 participants in 2 patient groups, including a placebo group

Formulation containing MLYAAT-1002® Composition

Active Comparator group

Description:

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.

Treatment:

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 group

Description:

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.

Treatment:

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