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CompletedNCT04583852Updated May 24, 2022

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

An interventional study of AIVÍA, Ultra-Brightening Spot Micro-needle Patch and Placebo Micro-needle Patch in Solar Lentigines, sponsored by Panion & BF Biotech Inc.. Completed at 1 site in Taiwan. Open to participants aged 30 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-24.

Sponsored by Panion & BF Biotech Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
35
Allocation
Randomized
Ages
30 Years to 65 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Solar Lentigines

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Keywords

  • Solar Lentigines
  • Micro-needle patch
03

In context

Lentigo

28 studies on the registry are indexed under Lentigo; 2 are open to participants now.

This study's enrollment of 35 is above the median of 30 across 25 interventional studies indexed under Lentigo.

Browse Lentigo studies →

Lead sponsor

Panion & BF Biotech Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
35 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherAIVÍA, Ultra-Brightening Spot Micro-needle Patch

    a dissolving micro-needle patch, contains active ingredients

  • OtherPlacebo Micro-needle Patch

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

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 4 week

Secondary outcomes

  1. 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)

    Time frame: 4 week

  2. 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)

    Time frame: 2 week

  3. the value change of melanin index of facial solar lentigines from baseline

    measure the melanin index by CK Mexameter at baseline and 2nd week

    Time frame: 2 week

  4. the value change of melanin index of facial solar lentigines from baseline

    measure the melanin index by CK Mexameter at baseline and 4th week

    Time frame: 4 week

  5. the percentage change of melanin index of facial solar lentigines from baseline

    measure the melanin index by CK Mexameter at baseline and 2nd week

    Time frame: 2 week

  6. the percentage change of melanin index of facial solar lentigines from baseline

    measure the melanin index by CK Mexameter at baseline and 4th week

    Time frame: 4 week

  7. 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

    Time frame: 2 week

  8. 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

    Time frame: 4 week

  9. 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

    Time frame: 2 week

  10. 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

    Time frame: 4 week

  11. 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

    Time frame: 2 week

  12. 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

    Time frame: 4 week

  13. assessing the patches safety on the skin by adverse reactions

    assess by the incidence of adverse reactions

    Time frame: through study completion, an average of 4 weeks

  14. assessing the patches safety on the skin by subject diary

    assess by subject diary

    Time frame: through study completion, an average of 4 weeks

  15. assessing the patches safety on the skin by skin response

    assess by skin response score sheets

    Time frame: through study completion, an average of 4 weeks

  16. assessing the subjects' compliance with the trial by subjects' return visits

    assess subjects' compliance by the number of the subjects' return visits

    Time frame: through study completion, an average of 4 weeks

  17. assessing the subjects' compliance with the trial by subject diary

    assess subjects' compliance by subject diary

    Time frame: through study completion, an average of 4 weeks

  18. 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

    Time frame: through study completion, an average of 4 weeks

  19. 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.

    Time frame: through study completion, an average of 4 weeks

07

Study locations

1 site
  • Department of Dermatology, National Taiwan University
    Taipei, 10002, Taiwan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04583852
Lead sponsor
Panion & BF Biotech Inc.
Responsible party
Sponsor
First posted
Oct 12, 2020
Start date
Sep 14, 2020
Primary completion
Jan 8, 2021
Completion
Jan 25, 2021
Last update
May 24, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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