A 56-day Clinical Study on Facial Skin Rejuvenation

Botanee Group

Status: Completed

Conditions: Skin Manifestations; Photoaging; Wrinkle

Treatments: Combination Product: Fractional picosecond laser treatment followed by daily use of formulations containing MLYAAT-1002®.; Combination Product: Fractional picosecond laser treatment followed by daily use of formulations without MLYAAT-1002®

Study type: Interventional

Funder types: Industry

Identifiers

NCT06188338

C23021036

Details and patient eligibility

About

This clinical trial aims to learn about the efficacy of MLYAAT-1002® (a proprietary anti-aging complex, MLYAAT is short for "multi-layer anti-ageing technology" ) in female subjects who have newly received the rejuvenation treatment by comparing visual clinical scores, skin attributes measurement and image analysis.

Full description

The main expectations are:

• After the 8-week continuous use of the test formulations with MLYAAT-1002® on one split-face side, the clinical manifestations and scores of photoaging improve compared to those of the control side using the placebo formulations.
• After the 8-week continuous use of the test formulations with MLYAAT-1002®, indicators of skin tone, individual type angle (ITA), CIELAB color space, pores and wrinkles improve compared to those of the control side using the placebo formulations.

Enrollment: 24 patients

Sex: Female

Ages: 30 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• self-reported facial aging problems such as roughness, fine lines, and dull skin
• no symptoms of itching, tingling, or burning on the face
• no symptoms of facial flushing, erythema, papules, desquamation, or spot haemorrhage as evaluated by a dermatologist
• photodamage scores above 2 (evaluated by a dermatologist)
• compliance with split-face use of the assigned formulations for 56 days
• no antibiotics remedy in the past three months
• regular use of sunscreen products at least five times a week
• no plans to leave Shanghai during the period of the trial
• compliance with no use of any cosmetics that may bias the study results during the period of the trial
• written informed consent and portrait right consent were obtained from all participants before study entry

Exclusion criteria

• female subjects who are pregnant, lactating or planning to become pregnant
• history of alcoholism
• history of allergies
• subjects who have received medical rejuvenation treatment within the past one year
• being a participant in any other clinical trial within the past one month
• subjects who are suffering from facial skin diseases (melasma, acne, and herpes simplex, etc.)
• subjects with scar constitution or that predispose to Koebner's phenomenon (such as vitiligo and lichen planus, etc.)
• subjects who had skin diseases (such as psoriasis, eczema, and skin cancer, etc.)
• taken/injected anti-allergy medication in the past one month
• subjects who had a high fever in the past 2 weeks
• received anticancer chemotherapy or immunotherapy in the past 6 months
• anyone that the investigator thinks of not eligible.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

24 participants in 2 patient groups, including a placebo group

Formulation containing MLYAAT-1002® Composition

Active Comparator group

Description:

After the 1064nm fractional picosecond laser treatment, daily use of the formulation for 56 days: apply one pump of the formulation to the treated side of the face in the morning and evening, respectively.

Treatment:

Combination Product: Fractional picosecond laser treatment followed by daily use of formulations containing MLYAAT-1002®.

Blank formulation without MLYAAT-1002® Composition

Placebo Comparator group

Description:

After the 1064nm fractional picosecond laser treatment, daily use of the blank formulation for 56 days: apply one pump of the blank formulation to the control side of the face in the morning and evening, respectively.

Treatment:

Combination Product: Fractional picosecond laser treatment followed by daily use of formulations without MLYAAT-1002®