A Single Center, Randomized, Double-blind and Placebo Controlled Clinical Study to Evaluate the Efficacy and Safety of Brightening Micro-needle Patch on Facial Solar Lentigines
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Solar Lentigines
- Sponsor
- Panion & BF Biotech Inc.
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- the percentage change of skin tone index ITA° value of facial solar lentigines from baseline
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
the percentage change of skin tone index ITA° value of facial solar lentigines from baseline
Time Frame: 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 Outcomes
- the value change of skin tone index ITA° value of facial solar lentigines from baseline(2 week)
- the value change of melanin index of facial solar lentigines from baseline(4 week)
- the percentage change of melanin index of facial solar lentigines from baseline(4 week)
- assessing the patches safety on the skin by skin response(through study completion, an average of 4 weeks)
- rating the improvement of facial solar lentigines on the facial image taken by VISIA, skin analysis imaging system(4 week)
- assessing the value change of skin tone index L*a*b* of facial solar lentigines from baseline(4 week)
- assessing the patches safety on the skin by adverse reactions(through study completion, an average of 4 weeks)
- assessing the percentage change of skin tone index L*a*b* of facial solar lentigines from baseline(4 week)
- assessing the patches safety on the skin by subject diary(through study completion, an average of 4 weeks)
- assessing the subjects' compliance with the trial by subjects' return visits(through study completion, an average of 4 weeks)
- assessing the subjects' compliance with the trial 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(through study completion, an average of 4 weeks)
- assessing the subjects' feedback of the patches(through study completion, an average of 4 weeks)