Photoaging, Skin Manifestations, Wrinkle
Conditions
Brief summary
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.
Detailed 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.
Interventions
COMBINATION_PRODUCTFractional picosecond laser treatment followed by daily use of formulations containing MLYAAT-1002®.
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.
COMBINATION_PRODUCTFractional picosecond laser treatment followed by daily use of formulations without MLYAAT-1002®
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.
Sponsors
Botanee Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in skin manifestations of photodamage (global score) | 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. |
| changes in skin manifestations of photodamage (tactile skin roughness) | 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. |
| changes in skin manifestations of photodamage (fine lines) | 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. |
| changes in skin manifestations of photodamage (coarse wrinkles) | 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. |
| changes in skin manifestations of photodamage (mottled pigmentation) | 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. |
| changes in skin manifestations of photodamage (erythema) | 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. |
| changes in skin manifestations of photodamage (dull skin) | 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. |
| changes in skin manifestations of photodamage (telangiectasia) | 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
| Measure | Time frame | Description |
|---|---|---|
| changes in the characteristics of crow's feet | 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 |
| changes in skin surface hydration(a.u.) of facial skin | 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) |
| self-assessment by participants | 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. |
| safety and tolerability | 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 . |
| changes in transepidermal water loss (TEWL#in g/m2/h) of facial skin | 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) |
| changes in index of erythema of facial skin | Day 0, Day 3, Day 5, Day 8, Day15, Day 29, Day 57 | measuring erythema by Mexameter MX18(Courage&Khazaka, Germany) |
| changes in index of melanin of facial skin | Day 0, Day 3, Day 5, Day 8, Day15, Day 29, Day 57 | measuring melanin by Mexameter MX18(Courage&Khazaka, Germany) |
| changes in individual typology angle (ITA°) of facial skin | 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 |
| changes in the percentage of facial skin pore area | 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 |
| changes in the characteristics of facial wrinkles （depth) | 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 |
| changes in the characteristics of facial wrinkles | 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 |
Countries
China
Outcome results
None listed