Evaluate the Efficacy and Safety of Brightening Micro-needle Patch on Facial Solar Lentigines

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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

Conditions
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Solar Lentigines

Intervention / Treatment
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* Other: AIVÍA, Ultra-Brightening Spot Micro-needle Patch
* Other: Placebo Micro-needle Patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Men or women between 30 and 65 years old (inclusive); The PI determines the subject's skin type as Fitzpatrick Skin Type II to IV; The PI's diagnosis is that the 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; The subject can understand and follow the requirements, instructions and restriction of the plan; The subject signs patient consent form in writing. Exclusion Criteria The PI's diagnosis is that the subject has tissue mutation, inflammation or other lesions on the face; Those who have received aggressive facial treatments within the past six months, including laser, IPL, RF (radio frequency), HIFU(high-intensity focus ultrasound), or dermal filler injection; Those with a history of chronic skin diseases or autoimmune diseases, such as atopic dermatitis, psoriasis, chronic urticaria, vitiligo, rosacea, keloid and so forth; Those who have a history of allergies to the product ingredients of the brightening micro-needle patch, the moisturizer or the sunscreen provided by the trial; Pregnant or lactating women; Those who have used facial blemish-lightening products (such as products claiming to have whitening or blemish-lightening effects), topical or oral whitening drugs within 21 days before entering the trial; Those who have smoking habits within 12 months before entering the trial; Those who have used any skin medication on the face within 30 days before entering the trial, determined by the PI to have effect on this study; Those who have participated in other clinical trials within 30 days before entering the trial; Those who are currently undergoing medical treatment and their ability to participate in this trial will be affected; Those who the PI considers to be unsuitable to join this trial.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: brightening micro-needle patch<br>apply brightening micro-needle patch to one of the two assigned spots on the face according to the instructions on the package | Other: AIVÍA, Ultra-Brightening Spot Micro-needle Patch<br>* a dissolving micro-needle patch, contains active ingredients<br>|
| Placebo Comparator: Placebo<br>apply placebo micro-needle patch to another one of the two assigned spots on the face according to the instructions on the package | Other: Placebo Micro-needle Patch<br>* matching placebo will be provided as a dissolving micro-needle patch<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Solar Lentigines, Micro-needle patch