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

Panion & BF Biotech

Status

Completed

Conditions

Solar Lentigines

Treatments

Other: Placebo Micro-needle Patch

Other: AIVÍA, Ultra-Brightening Spot Micro-needle Patch

Study type

Interventional

Funder types

Industry

Identifiers

NCT04583852

PBF-MN-01

Details and patient eligibility

About

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.

Full 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).

Enrollment

35 patients

Sex

All

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.