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Completed

NCT Number: NCT06188338

A 56-day Clinical Study on Facial Skin Rejuvenation

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.

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Key information

Conditions

Skin Manifestations Pathological Conditions, Signs and Symptoms Photoaging Signs and Symptoms Wrinkle

Age range

30 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai China-norm Quality Technical Service Co ，Ltd

Shanghai, Shanghai Municipality, 200072, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Combination Product

Each subject will receive a single treatment of the fractional picosecond laser, followed by the first application of the active comparator on the randomly assigned side of the split-face (the treatment side) on the same day, and sequently, will apply the active comparator to this side twice a day for 56 days.

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

Combination Product

Each subject will receive a single treatment of the fractional picosecond laser, followed by the first application of the placebo comparator on the randomly assigned side of the split-face (the control side) on the same day, and sequently, will apply the placebo comparator to this side twice a day for 56 days.

Primary outcomes

  1. changes in skin manifestations of photodamage (global score)

    Time frame: Day 0, Day 15, Day 29, Day 57

    Scoring by two independent dermatologists, a global score of facial skin on a 5-point scale (0-4) will be recorded, i.e., lower scores meaning a better outcome.

  2. changes in skin manifestations of photodamage (tactile skin roughness)

    Time frame: Day 0, Day 15, Day 29, Day 57

    Scoring by two independent dermatologists, a roughness score of facial skin on a 5-point scale (0-4) will be recorded, i.e., lower scores meaning a better outcome.

  3. changes in skin manifestations of photodamage (fine lines)

    Time frame: Day 0, Day 15, Day 29, Day 57

    Scoring by two independent dermatologists, a fine-line score of facial skin on a 5-point scale (0-4) will be recorded, i.e., lower scores meaning a better outcome.

  4. changes in skin manifestations of photodamage (coarse wrinkles)

    Time frame: Day 0, Day 15, Day 29, Day 57

    Scoring by two independent dermatologists, a coarse-wrinkle score of facial skin on a 5-point scale (0-4) will be recorded, i.e., lower scores meaning a better outcome.

  5. changes in skin manifestations of photodamage (mottled pigmentation)

    Time frame: Day 0, Day 15, Day 29, Day 57

    Scoring by two independent dermatologists, a pigmentation score of facial skin on a 5-point scale (0-4) will be recorded, i.e., lower scores meaning a better outcome.

  6. changes in skin manifestations of photodamage (erythema)

    Time frame: Day 0, Day 15, Day 29, Day 57

    Scoring by two independent dermatologists, an erythema score of facial skin on a 5-point scale (0-4) will be recorded, i.e., lower scores meaning a better outcome.

  7. changes in skin manifestations of photodamage (dull skin)

    Time frame: Day 0, Day 15, Day 29, Day 57

    Scoring by two independent dermatologists, a dull-skin score of facial skin on a 5-point scale (0-4) will be recorded, i.e., lower scores meaning a better outcome.

  8. changes in skin manifestations of photodamage (telangiectasia)

    Time frame: Day 0, Day 15, Day 29, Day 57

    Scoring by two independent dermatologists, a telangiectasia score of facial skin on a 5-point scale (0-4) will be recorded, i.e., lower scores meaning a better outcome.

Secondary outcomes

  1. changes in skin surface hydration(a.u.) of facial skin

    Time frame: Day 0, Day 3, Day 5, Day 8, Day15, Day 29, Day 57

    measuring hydration of the stratum corneum by Corneometer® MPA580 (Courage&Khazaka#Germany)

  2. changes in transepidermal water loss (TEWL#in g/m2/h) of facial skin

    Time frame: Day 0, Day 3, Day 5, Day 8, Day15, Day 29, Day 57

    measuring the loss of water that passes from inside a body through the epidermis to the surrounding atmosphere by Tewameter® MPA580 (Courage&Khazaka#Germany)

  3. changes in index of erythema of facial skin

    Time frame: Day 0, Day 3, Day 5, Day 8, Day15, Day 29, Day 57

    measuring erythema by Mexameter MX18(Courage&Khazaka, Germany)

  4. changes in index of melanin of facial skin

    Time frame: Day 0, Day 3, Day 5, Day 8, Day15, Day 29, Day 57

    measuring melanin by Mexameter MX18(Courage&Khazaka, Germany)

  5. changes in individual typology angle (ITA°) of facial skin

    Time frame: Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57

    capturing facial images by VISIA-7 (CANFIELD, America) and calculating the ITA

  6. changes in the percentage of facial skin pore area

    Time frame: Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57

    capturing facial images by VISIA-7 (CANFIELD, America) and calculating the percentage of pore area

  7. changes in the characteristics of facial wrinkles （depth)

    Time frame: Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57

    capturing facial images by VISIA-7 (CANFIELD, America), and recording the depth of wrinkles at the specific face region

  8. changes in the characteristics of facial wrinkles

    Time frame: Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57

    capturing facial images by VISIA-7 (CANFIELD, America), and recording the area of wrinkles at the specific face region

  9. changes in the characteristics of crow's feet

    Time frame: Day 0, Day 29, Day 57

    capturing facial images by Primos (CANFIELD, America) and calculating the area of crow's feet at the specific face region

  10. safety and tolerability

    Time frame: Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57

    Any adverse effects (e.g., erythema, flush, stinging, pruritus, and spot hemorrhage, desquamation) on both sides of face will be recorded at each visit by two independent dermatologists. The severity of the observed effect will be scored on a 5-point scale (0-4) , i.e., higher scores meaning a more severe level .

  11. self-assessment by participants

    Time frame: Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57

    All the particpants will be asked to report any discomfort (e.g., stinging, pruritus, burning sensation) in their faces at each visit. The severity of the reported discomfort will be scored on a 5-point scale (0-4) , i.e., higher scores meaning a more severe level.

Sponsors and collaborators

Lead sponsor

Botanee Group Co., Ltd.

Industry

Registry information

Official study title

Clinical Study on 56-Day Continuous Improvement of 1064nm Fractional Picosecond Laser Treatment With Formulations of A Proprietary Anti-aging Complex Composition

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 3, 2024
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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