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

NCT ID: NCT04583852

Last Updated: 2022-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-14
• Study Completion Date: 2021-01-25

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).

Conditions

Solar Lentigines

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

brightening micro-needle patch

apply brightening micro-needle patch to one of the two assigned spots on the face according to the instructions on the package

Group Type: EXPERIMENTAL

AIVÍA, Ultra-Brightening Spot Micro-needle Patch

Intervention Type: OTHER

a dissolving micro-needle patch, contains active ingredients

Placebo

apply placebo micro-needle patch to another one of the two assigned spots on the face according to the instructions on the package

Group Type: PLACEBO_COMPARATOR

Placebo Micro-needle Patch

Intervention Type: OTHER

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

Interventions

AIVÍA, Ultra-Brightening Spot Micro-needle Patch

a dissolving micro-needle patch, contains active ingredients

Intervention Type: OTHER

Placebo Micro-needle Patch

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Panion & BF Biotech Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Dermatology, National Taiwan University

Taipei, , Taiwan

Countries

Taiwan

Other Identifiers

PBF-MN-01

Identifier Type: -

Identifier Source: org_study_id