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Completed

NCT Number: NCT04583852

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.

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Key information

Conditions

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Dermatology, National Taiwan University

Taipei, 10002, Taiwan

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men or women between 30 and 65 years old (inclusive);
  • The PI determines the subject's skin type as Fitzpatrick Skin Type II to IV;
  • 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;
  • The subject can understand and follow the requirements, instructions and restriction of the plan;
  • The subject signs patient consent form in writing.

Exclusion criteria

  • The PI's diagnosis is that the subject has tissue mutation, inflammation or other lesions on the face;
  • 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;
  • Those with a history of chronic skin diseases or autoimmune diseases, such as atopic dermatitis, psoriasis, chronic urticaria, vitiligo, rosacea, keloid and so forth;
  • 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;
  • Pregnant or lactating women;
  • 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;
  • Those who have smoking habits within 12 months before entering the trial;
  • 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;
  • Those who have participated in other clinical trials within 30 days before entering the trial;
  • Those who are currently undergoing medical treatment and their ability to participate in this trial will be affected;
  • Those who the PI considers to be unsuitable to join this trial.

Treatment and study plan

AIVÍA, Ultra-Brightening Spot Micro-needle Patch

Other

a dissolving micro-needle patch, contains active ingredients

Placebo Micro-needle Patch

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Panion & BF Biotech Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 12, 2020
Registry last updated
May 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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