Back to resultsEvaluate the Efficacy and Safety of Brightening Micro-needle Patch on Facial Solar Lentigines
Primary Purpose
Solar Lentigines
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
AIVÍA, Ultra-Brightening Spot Micro-needle Patch
Placebo Micro-needle Patch
Sponsored by
About this trial
This is an interventional treatment trial for Solar Lentigines focused on measuring Solar Lentigines, Micro-needle patch
Eligibility Criteria
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.
Sites / Locations
- Department of Dermatology, National Taiwan University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
brightening micro-needle patch
Placebo
Arm Description
apply brightening micro-needle patch to one of the two assigned spots on the face according to the instructions on the package
apply placebo micro-needle patch to another one of the two assigned spots on the face according to the instructions on the package
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
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)
the value change of melanin index of facial solar lentigines from baseline
measure the melanin index by CK Mexameter at baseline and 2nd 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
the percentage change of melanin index of facial solar lentigines from baseline
measure the melanin index by CK Mexameter at baseline and 2nd 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
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
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
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
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
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
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
assessing the patches safety on the skin by adverse reactions
assess by the incidence of adverse reactions
assessing the patches safety on the skin by subject diary
assess by subject diary
assessing the patches safety on the skin by skin response
assess by skin response score sheets
assessing the subjects' compliance with the trial by subjects' return visits
assess subjects' compliance by the number of the subjects' return visits
assessing the subjects' compliance with the trial by subject diary
assess subjects' compliance by subject diary
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
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.
Full Information
NCT ID
NCT04583852
First Posted
September 10, 2020
Last Updated
May 23, 2022
Sponsor
Panion & BF Biotech Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04583852
Brief Title
Evaluate the Efficacy and Safety of Brightening Micro-needle Patch on Facial Solar Lentigines
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
September 14, 2020 (Actual)
Primary Completion Date
January 8, 2021 (Actual)
Study Completion Date
January 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Panion & BF Biotech Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Solar Lentigines
Keywords
Solar Lentigines, Micro-needle patch
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
brightening micro-needle patch
Arm Type
Experimental
Arm Description
apply brightening micro-needle patch to one of the two assigned spots on the face according to the instructions on the package
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
apply placebo micro-needle patch to another one of the two assigned spots on the face according to the instructions on the package
Intervention Type
Other
Intervention Name(s)
AIVÍA, Ultra-Brightening Spot Micro-needle Patch
Intervention Description
a dissolving micro-needle patch, contains active ingredients
Intervention Type
Other
Intervention Name(s)
Placebo Micro-needle Patch
Intervention Description
matching placebo will be provided as a dissolving micro-needle patch
Primary Outcome Measure Information:
Title
the percentage change of skin tone index ITA° value of facial solar lentigines from baseline
Description
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 Outcome Measure Information:
Title
the value change of skin tone index ITA° value of facial solar lentigines from baseline
Description
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
Title
the value change of skin tone index ITA° value of facial solar lentigines from baseline
Description
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
Title
the value change of melanin index of facial solar lentigines from baseline
Description
measure the melanin index by CK Mexameter at baseline and 2nd week
Time Frame
2 week
Title
the value change of melanin index of facial solar lentigines from baseline
Description
measure the melanin index by CK Mexameter at baseline and 4th week
Time Frame
4 week
Title
the percentage change of melanin index of facial solar lentigines from baseline
Description
measure the melanin index by CK Mexameter at baseline and 2nd week
Time Frame
2 week
Title
the percentage change of melanin index of facial solar lentigines from baseline
Description
measure the melanin index by CK Mexameter at baseline and 4th week
Time Frame
4 week
Title
rating the improvement of facial solar lentigines on the facial image taken by VISIA, skin analysis imaging system
Description
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
Title
rating the improvement of facial solar lentigines on the facial image taken by VISIA, skin analysis imaging system
Description
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
Title
assessing the value change of skin tone index L*a*b* of facial solar lentigines from baseline
Description
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
Title
assessing the value change of skin tone index L*a*b* of facial solar lentigines from baseline
Description
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
Title
assessing the percentage change of skin tone index L*a*b* of facial solar lentigines from baseline
Description
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
Title
assessing the percentage change of skin tone index L*a*b* of facial solar lentigines from baseline
Description
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
Title
assessing the patches safety on the skin by adverse reactions
Description
assess by the incidence of adverse reactions
Time Frame
through study completion, an average of 4 weeks
Title
assessing the patches safety on the skin by subject diary
Description
assess by subject diary
Time Frame
through study completion, an average of 4 weeks
Title
assessing the patches safety on the skin by skin response
Description
assess by skin response score sheets
Time Frame
through study completion, an average of 4 weeks
Title
assessing the subjects' compliance with the trial by subjects' return visits
Description
assess subjects' compliance by the number of the subjects' return visits
Time Frame
through study completion, an average of 4 weeks
Title
assessing the subjects' compliance with the trial by subject diary
Description
assess subjects' compliance by subject diary
Time Frame
through study completion, an average of 4 weeks
Title
assessing the subjects' compliance with the trial by the number of patches packages returned
Description
assess subjects' compliance by the number of patches packages returned by the subjects
Time Frame
through study completion, an average of 4 weeks
Title
assessing the subjects' feedback of the patches
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Department of Dermatology, National Taiwan University
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Evaluate the Efficacy and Safety of Brightening Micro-needle Patch on Facial Solar Lentigines
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