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

A Single Center, Randomized, Double-blind and Placebo Controlled Clinical Study to Evaluate the Efficacy and Safety of Brightening Micro-needle Patch on Facial Solar Lentigines

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.

Study Overview

• Status: Completed
• Conditions: Solar Lentigines
• Intervention / Treatment: Other: AIVÍA, Ultra-Brightening Spot Micro-needle Patch; Other: Placebo Micro-needle Patch

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).

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 10002
    • Department of Dermatology, National Taiwan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: AIVÍA, Ultra-Brightening Spot Micro-needle Patch; a dissolving micro-needle patch, contains active ingredients
Placebo Comparator: Placebo; apply placebo micro-needle patch to another one of the two assigned spots on the face according to the instructions on the package	Other: Placebo Micro-needle Patch; matching placebo will be provided as a dissolving micro-needle patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	4 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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	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	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	2 week
the percentage change of melanin index of facial solar lentigines from baseline	measure the melanin index by CK Mexameter at baseline and 4th week	4 week
rating the improvement of facial solar lentigines on the facial image taken by VISIA, skin analysis imaging system	use Physician Global Assessment (PGA) to assess the percentage improvement of lesions using VISIA images , with a scale of -1 to 5	2 week
rating the improvement of facial solar lentigines on the facial image taken by VISIA, skin analysis imaging system	use Physician Global Assessment (PGA) to assess the percentage improvement of lesions using VISIA images , with a scale of -1 to 5	4 week
assessing the value change of skin tone index L*a*b* of facial solar lentigines from baseline	determine the facial spot color index L*a*b* by color meter (CR-400 Chroma Meter) at baseline and 2nd week	2 week
assessing the value change of skin tone index L*a*b* of facial solar lentigines from baseline	determine the facial spot color index L*a*b* by color meter (CR-400 Chroma Meter) at baseline and 4th week	4 week
assessing the percentage change of skin tone index L*a*b* of facial solar lentigines from baseline	determine the facial spot color index L*a*b* by color meter (CR-400 Chroma Meter) at baseline and 2nd week	2 week
assessing the percentage change of skin tone index L*a*b* of facial solar lentigines from baseline	determine the facial spot color index L*a*b* by color meter (CR-400 Chroma Meter) at baseline and 4th week	4 week
assessing the patches safety on the skin by adverse reactions	assess by the incidence of adverse reactions	through study completion, an average of 4 weeks
assessing the patches safety on the skin by subject diary	assess by subject diary	through study completion, an average of 4 weeks
assessing the patches safety on the skin by skin response	assess by skin response score sheets	through study completion, an average of 4 weeks
assessing the subjects' compliance with the trial by subjects' return visits	assess subjects' compliance by the number of the subjects' return visits	through study completion, an average of 4 weeks
assessing the subjects' compliance with the trial by subject diary	assess subjects' compliance by subject diary	through study completion, an average of 4 weeks
assessing the subjects' compliance with the trial by the number of patches packages returned	assess subjects' compliance by the number of patches packages returned by the subjects	through study completion, an average of 4 weeks
assessing the subjects' feedback of the patches	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.	through study completion, an average of 4 weeks

Collaborators and Investigators

• Sponsor: Panion & BF Biotech Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2020
• Primary Completion (Actual): January 8, 2021
• Study Completion (Actual): January 25, 2021

Study Registration Dates

• First Submitted: September 10, 2020
• First Submitted That Met QC Criteria: October 6, 2020
• First Posted (Actual): October 12, 2020

Study Record Updates

• Last Update Posted (Actual): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 23, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Solar Lentigines; Micro-needle patch
• Additional Relevant MeSH Terms: Skin Diseases; Hyperpigmentation; Pigmentation Disorders; Melanosis; Lentigo
• Other Study ID Numbers: PBF-MN-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No