Evaluate the Efficacy and Safety of Brightening Micro-needle Patch on Facial Solar Lentigines
- Conditions
- Solar Lentigines
- Interventions
- Other: AIVÍA, Ultra-Brightening Spot Micro-needle PatchOther: Placebo Micro-needle Patch
- Registration Number
- NCT04583852
- Lead Sponsor
- Panion & BF Biotech Inc.
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description brightening micro-needle patch AIVÍA, Ultra-Brightening Spot Micro-needle Patch apply brightening micro-needle patch to one of the two assigned spots on the face according to the instructions on the package Placebo Placebo Micro-needle Patch apply placebo micro-needle patch to another one of the two assigned spots on the face according to the instructions on the package
- Primary Outcome Measures
Name Time Method the percentage change of skin tone index ITA° value of facial solar lentigines from baseline 4 week 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)
- Secondary Outcome Measures
Name Time Method the value change of skin tone index ITA° value of facial solar lentigines from baseline 2 week 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)
the value change of melanin index of facial solar lentigines from baseline 4 week measure the melanin index by CK Mexameter at baseline and 4th week
the percentage change of melanin index of facial solar lentigines from baseline 4 week measure the melanin index by CK Mexameter at baseline and 4th week
assessing the patches safety on the skin by skin response through study completion, an average of 4 weeks assess by skin response score sheets
rating the improvement of facial solar lentigines on the facial image taken by VISIA, skin analysis imaging system 4 week use Physician Global Assessment (PGA) to assess the percentage improvement of lesions using VISIA images , with a scale of -1 to 5
assessing the value change of skin tone index L*a*b* of facial solar lentigines from baseline 4 week determine the facial spot color index L\*a\*b\* by color meter (CR-400 Chroma Meter) at baseline and 4th week
assessing the patches safety on the skin by adverse reactions through study completion, an average of 4 weeks assess by the incidence of adverse reactions
assessing the percentage change of skin tone index L*a*b* of facial solar lentigines from baseline 4 week determine the facial spot color index L\*a\*b\* by color meter (CR-400 Chroma Meter) at baseline and 4th week
assessing the patches safety on the skin by subject diary through study completion, an average of 4 weeks assess by subject diary
assessing the subjects' compliance with the trial by subjects' return visits through study completion, an average of 4 weeks assess subjects' compliance by the number of the subjects' return visits
assessing the subjects' compliance with the trial by subject diary through study completion, an average of 4 weeks assess subjects' compliance by subject diary
assessing the subjects' compliance with the trial by the number of patches packages returned through study completion, an average of 4 weeks assess subjects' compliance by the number of patches packages returned by the subjects
assessing the subjects' feedback of the patches through study completion, an average of 4 weeks 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.
Trial Locations
- Locations (1)
Department of Dermatology, National Taiwan University
🇨🇳Taipei, Taiwan