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

Solar Lentigines Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04583852
• Other study ID #: PBF-MN-01
• Status: Completed
• Phase: N/A
• Start date: September 14, 2020
• Est. completion date: January 25, 2021

Study information

• Verified date: May 2022
• Source: Panion & BF Biotech Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 25, 2021
• Est. primary completion date: January 8, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lentigo
• Solar Lentigines

Intervention

Other:
• AIVÍA, Ultra-Brightening Spot Micro-needle Patch
a dissolving micro-needle patch, contains active ingredients
• Placebo Micro-needle Patch
matching placebo will be provided as a dissolving micro-needle patch

Locations

Country	Name	City	State
Taiwan	Department of Dermatology, National Taiwan University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Panion & BF Biotech Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	assessing the patches safety on the skin by subject diary	assess by subject diary	through study completion, an average of 4 weeks
Secondary	assessing the patches safety on the skin by skin response	assess by skin response score sheets	through study completion, an average of 4 weeks
Secondary	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
Secondary	assessing the subjects' compliance with the trial by subject diary	assess subjects' compliance by subject diary	through study completion, an average of 4 weeks
Secondary	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
Secondary	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