Solar Lentigines
Conditions
Keywords
Solar Lentigines, Micro-needle patch
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).
Interventions
OTHERAIVÍA, Ultra-Brightening Spot Micro-needle Patch
a dissolving micro-needle patch, contains active ingredients
OTHERPlacebo Micro-needle Patch
matching placebo will be provided as a dissolving micro-needle patch
Sponsors
Panion & BF Biotech Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
1. Men or women between 30 and 65 years old (inclusive); 2. The PI determines the subject's skin type as Fitzpatrick Skin Type II to IV; 3. 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; 4. The subject can understand and follow the requirements, instructions and restriction of the plan; 5. The subject signs patient consent form in writing.
Exclusion criteria
1. The PI's diagnosis is that the subject has tissue mutation, inflammation or other lesions on the face; 2. 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; 3. Those with a history of chronic skin diseases or autoimmune diseases, such as atopic dermatitis, psoriasis, chronic urticaria, vitiligo, rosacea, keloid and so forth; 4. 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; 5. Pregnant or lactating women; 6. 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; 7. Those who have smoking habits within 12 months before entering the trial; 8. 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; 9. Those who have participated in other clinical trials within 30 days before entering the trial; 10. Those who are currently undergoing medical treatment and their ability to participate in this trial will be affected; 11. Those who the PI considers to be unsuitable to join this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| the value change of melanin index of facial solar lentigines from baseline | 2 week | measure the melanin index by CK Mexameter at baseline and 2nd week |
| the percentage change of melanin index of facial solar lentigines from baseline | 2 week | measure the melanin index by CK Mexameter at baseline and 2nd week |
| rating the improvement of facial solar lentigines on the facial image taken by VISIA, skin analysis imaging system | 2 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 | 2 week | determine the facial spot color index L\*a\*b\* by color meter (CR-400 Chroma Meter) at baseline and 2nd week |
| assessing the percentage change of skin tone index L*a*b* of facial solar lentigines from baseline | 2 week | determine the facial spot color index L\*a\*b\* by color meter (CR-400 Chroma Meter) at baseline and 2nd 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 |
| the value change of skin tone index ITA° value of facial solar lentigines from baseline | 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) |
| assessing the patches safety on the skin by skin response | through study completion, an average of 4 weeks | assess by skin response score sheets |
| 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. |
| assessing the patches safety on the skin by subject diary | through study completion, an average of 4 weeks | assess by subject diary |
Countries
Taiwan
Outcome results
None listed