Department of Dermatology, National Taiwan University
Taipei, 10002, Taiwan
NCT Number: NCT04583852
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.
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Notify Me30 year–65 year
All sexes
Interventional
Not applicable
Taipei, 10002, Taiwan
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
a dissolving micro-needle patch, contains active ingredients
matching placebo will be provided as a dissolving micro-needle patch
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)
Time frame: 4 week
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)
Time frame: 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)
Time frame: 2 week
measure the melanin index by CK Mexameter at baseline and 2nd week
Time frame: 4 week
measure the melanin index by CK Mexameter at baseline and 4th week
Time frame: 2 week
measure the melanin index by CK Mexameter at baseline and 2nd week
Time frame: 4 week
measure the melanin index by CK Mexameter at baseline and 4th week
Time frame: 2 week
use Physician Global Assessment (PGA) to assess the percentage improvement of lesions using VISIA images , with a scale of -1 to 5
Time frame: 4 week
use Physician Global Assessment (PGA) to assess the percentage improvement of lesions using VISIA images , with a scale of -1 to 5
Time frame: 2 week
determine the facial spot color index L*a*b* by color meter (CR-400 Chroma Meter) at baseline and 2nd week
Time frame: 4 week
determine the facial spot color index L*a*b* by color meter (CR-400 Chroma Meter) at baseline and 4th week
Time frame: 2 week
determine the facial spot color index L*a*b* by color meter (CR-400 Chroma Meter) at baseline and 2nd week
Time frame: 4 week
determine the facial spot color index L*a*b* by color meter (CR-400 Chroma Meter) at baseline and 4th week
Time frame: through study completion, an average of 4 weeks
assess by the incidence of adverse reactions
Time frame: through study completion, an average of 4 weeks
assess by subject diary
Time frame: through study completion, an average of 4 weeks
assess by skin response score sheets
Time frame: through study completion, an average of 4 weeks
assess subjects' compliance by the number of the subjects' return visits
Time frame: through study completion, an average of 4 weeks
assess subjects' compliance by subject diary
Time frame: through study completion, an average of 4 weeks
assess subjects' compliance by the number of patches packages returned by the subjects
Time frame: 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.
Panion & BF Biotech Inc.
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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