Evaluate the Efficacy and Safety of Brightening Micro-needle Patch on Facial Solar Lentigines (NCT04583852) | Clinical Trial Compass
CompletedNot Applicable
Evaluate the Efficacy and Safety of Brightening Micro-needle Patch on Facial Solar Lentigines
Taiwan35 participantsStarted 2020-09-14
Plain-language 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.
Who can participate
Age range30 Years – 65 Years
SexALL
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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;
What they're measuring
1
the percentage change of skin tone index ITA° value of facial solar lentigines from baseline