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This is a single center, randomized, double-blind and placebo controlled clinical study to evaluate the efficacy and safety of brightening microneedle patch on facial solar lentigines. Subjects who are 30 to 65-year-old with solar lentigines on their faces will receive brightening microneedle patches on facial solar lentigines once a day for 4 weeks. Afterwards, facial images and skin detectors will be used to analysis their skin, according to various skin tone indexes and skin response score sheets.
Method: 35 subjects, Fitzpatrick Skin Type II to IV. Each subject has at least two brown solar lentigines on the face, and the two spots are independent, each with a clear boundary and diameter ≥ 0.5 cm.
This trial includes 1 screening visit (Day -1), wash-out period (2 weeks before the trial), trial period (4 weeks in total), and 3 return visits for detecting (baseline detecting at the end of the wash-out period, the 2nd week and the 4th week of the trial period).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| brightening micro-needle patch | Experimental | apply brightening micro-needle patch to one of the two assigned spots on the face according to the instructions on the package |
|
| Placebo | Placebo Comparator | apply placebo micro-needle patch to another one of the two assigned spots on the face according to the instructions on the package |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AIVÍA, Ultra-Brightening Spot Micro-needle Patch | Other | a dissolving micro-needle patch, contains active ingredients |
|
| Measure | Description | Time Frame |
|---|---|---|
| the percentage change of skin tone index ITA° value of facial solar lentigines from baseline | measure L* (luminance) and b* (yellow/blue component) values at baseline and 4th week by color meter (CR-400 Chroma Meter) to assess the ITA° percentage change. (ITA°=tangent arc((L*-50)/b*) 180/3.14159) | 4 week |
| Measure | Description | Time Frame |
|---|---|---|
| the value change of skin tone index ITA° value of facial solar lentigines from baseline | measure L* (luminance) and b* (yellow/blue component) values by color meter (CR-400 Chroma Meter) at baseline and 4th week to assess the ITA° value change. (ITA°=tangent arc((L*-50)/b*) 180/3.14159) | 4 week |
| the value change of skin tone index ITA° value of facial solar lentigines from baseline |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, National Taiwan University | Taipei | 10002 | Taiwan |
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| Placebo Micro-needle Patch | Other | matching placebo will be provided as a dissolving micro-needle patch |
|
measure L* (luminance) and b* (yellow/blue component) values by color meter (CR-400 Chroma Meter) at baseline and 2nd week to assess the ITA° value change. (ITA°=tangent arc((L*-50)/b*) 180/3.14159) |
| 2 week |
| the value change of melanin index of facial solar lentigines from baseline | measure the melanin index by CK Mexameter at baseline and 2nd week | 2 week |
| the value change of melanin index of facial solar lentigines from baseline | measure the melanin index by CK Mexameter at baseline and 4th week | 4 week |
| the percentage change of melanin index of facial solar lentigines from baseline | measure the melanin index by CK Mexameter at baseline and 2nd week | 2 week |
| the percentage change of melanin index of facial solar lentigines from baseline | measure the melanin index by CK Mexameter at baseline and 4th week | 4 week |
| rating the improvement of facial solar lentigines on the facial image taken by VISIA, skin analysis imaging system | use Physician Global Assessment (PGA) to assess the percentage improvement of lesions using VISIA images , with a scale of -1 to 5 | 2 week |
| rating the improvement of facial solar lentigines on the facial image taken by VISIA, skin analysis imaging system | use Physician Global Assessment (PGA) to assess the percentage improvement of lesions using VISIA images , with a scale of -1 to 5 | 4 week |
| assessing the value change of skin tone index L*a*b* of facial solar lentigines from baseline | determine the facial spot color index L*a*b* by color meter (CR-400 Chroma Meter) at baseline and 2nd week | 2 week |
| assessing the value change of skin tone index L*a*b* of facial solar lentigines from baseline | determine the facial spot color index L*a*b* by color meter (CR-400 Chroma Meter) at baseline and 4th week | 4 week |
| assessing the percentage change of skin tone index L*a*b* of facial solar lentigines from baseline | determine the facial spot color index L*a*b* by color meter (CR-400 Chroma Meter) at baseline and 2nd week | 2 week |
| assessing the percentage change of skin tone index L*a*b* of facial solar lentigines from baseline | determine the facial spot color index L*a*b* by color meter (CR-400 Chroma Meter) at baseline and 4th week | 4 week |
| assessing the patches safety on the skin by adverse reactions | assess by the incidence of adverse reactions | through study completion, an average of 4 weeks |
| assessing the patches safety on the skin by subject diary | assess by subject diary | through study completion, an average of 4 weeks |
| assessing the patches safety on the skin by skin response | assess by skin response score sheets | through study completion, an average of 4 weeks |
| assessing the subjects' compliance with the trial by subjects' return visits | assess subjects' compliance by the number of the subjects' return visits | through study completion, an average of 4 weeks |
| assessing the subjects' compliance with the trial by subject diary | assess subjects' compliance by subject diary | through study completion, an average of 4 weeks |
| assessing the subjects' compliance with the trial by the number of patches packages returned | assess subjects' compliance by the number of patches packages returned by the subjects | through study completion, an average of 4 weeks |
| assessing the subjects' feedback of the patches | assess the questionnaire completed by the subjects. Items in the questionnaire include satisfaction, patch usability, patch shape, patch size, skin quality after using the patch, issues with product use, etc. | through study completion, an average of 4 weeks |