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

Panion & BF Biotech Inc.35 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Solar Lentigines

Interventions

AIVÍA, Ultra-Brightening Spot Micro-needle PatchOTHER

a dissolving micro-needle patch, contains active ingredients

Placebo Micro-needle PatchOTHER

matching placebo will be provided as a dissolving micro-needle patch

Eligibility

Sex: ALLMin age: 30 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Department of Dermatology, National Taiwan University

Taipei, Taiwan

Outcomes

Primary Outcomes

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)

Time frame: 4 week

Secondary Outcomes

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)

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 2 week

Data from ClinicalTrials.gov

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