Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
The main expectations are:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Formulation containing MLYAAT-1002® Composition | Active Comparator | 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. |
|
| Blank formulation without MLYAAT-1002® Composition | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| changes in skin manifestations of photodamage (global score) | 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. | Day 0, Day 15, Day 29, Day 57 |
| changes in skin manifestations of photodamage (tactile skin roughness) | 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. | Day 0, Day 15, Day 29, Day 57 |
| changes in skin manifestations of photodamage (fine lines) | 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. | Day 0, Day 15, Day 29, Day 57 |
| changes in skin manifestations of photodamage (coarse wrinkles) | 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. | Day 0, Day 15, Day 29, Day 57 |
| changes in skin manifestations of photodamage (mottled pigmentation) | 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. | Day 0, Day 15, Day 29, Day 57 |
| changes in skin manifestations of photodamage (erythema) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| changes in skin surface hydration(a.u.) of facial skin | measuring hydration of the stratum corneum by Corneometer® MPA580 (Courage&Khazaka#Germany) | Day 0, Day 3, Day 5, Day 8, Day15, Day 29, Day 57 |
| changes in transepidermal water loss (TEWL#in g/m2/h) of facial skin |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yan Shuxian, Dr | Shanghai Yaokang Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai China-norm Quality Technical Service Co ，Ltd | Shanghai | Shanghai Municipality | 200072 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| Day 0, Day 15, Day 29, Day 57 |
| changes in skin manifestations of photodamage (dull skin) | 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. | Day 0, Day 15, Day 29, Day 57 |
| changes in skin manifestations of photodamage (telangiectasia) | 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. | Day 0, Day 15, 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) |
| Day 0, Day 3, Day 5, Day 8, Day15, Day 29, Day 57 |
| changes in index of erythema of facial skin | measuring erythema by Mexameter MX18(Courage&Khazaka, Germany) | Day 0, Day 3, Day 5, Day 8, Day15, Day 29, Day 57 |
| changes in index of melanin of facial skin | measuring melanin by Mexameter MX18(Courage&Khazaka, Germany) | Day 0, Day 3, Day 5, Day 8, Day15, Day 29, Day 57 |
| changes in individual typology angle (ITA°) of facial skin | capturing facial images by VISIA-7 (CANFIELD, America) and calculating the ITA | Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57 |
| changes in the percentage of facial skin pore area | capturing facial images by VISIA-7 (CANFIELD, America) and calculating the percentage of pore area | Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57 |
| changes in the characteristics of facial wrinkles （depth) | capturing facial images by VISIA-7 (CANFIELD, America), and recording the depth of wrinkles at the specific face region | Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57 |
| changes in the characteristics of facial wrinkles | capturing facial images by VISIA-7 (CANFIELD, America), and recording the area of wrinkles at the specific face region | Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57 |
| changes in the characteristics of crow's feet | capturing facial images by Primos (CANFIELD, America) and calculating the area of crow's feet at the specific face region | Day 0, Day 29, Day 57 |
| safety and tolerability | 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 . | Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57 |
| self-assessment by participants | 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. | Day 0, Day 1, Day 3, Day 5, Day 8, Day15, Day 29, Day 57 |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided