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

• ClinicalTrials.gov Identifier: NCT04583852
• Recruitment Status: Enrolling by invitation
• First Posted: October 12, 2020
• Last Update Posted: March 10, 2021
• Sponsor: Panion & BF Biotech Inc.
• Information provided by (Responsible Party): Panion & BF Biotech Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Solar Lentigines	Other: AIVÍA, Ultra-Brightening Spot Micro-needle Patch; Other: Placebo Micro-needle Patch	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: September 14, 2020
• Estimated Primary Completion Date: March 2021
• Estimated Study Completion Date: April 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. the percentage change of skin tone index ITA° value of facial solar lentigines from baseline [ Time Frame: 4 week ]
   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)

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

Taiwan

Department of Dermatology, National Taiwan University

Taipei, Taiwan, 10002

Sponsors and Collaborators

Panion & BF Biotech Inc.

More Information

• Responsible Party: Panion & BF Biotech Inc.
• ClinicalTrials.gov Identifier: NCT04583852
• Other Study ID Numbers: PBF-MN-01
• First Posted: October 12, 2020
• Last Update Posted: March 10, 2021
• Last Verified: October 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Panion & BF Biotech Inc.:

Solar Lentigines; Micro-needle patch

Additional relevant MeSH terms:

Lentigo; Melanosis; Hyperpigmentation; Pigmentation Disorders; Skin Diseases