Solar LentiginesNCT04583852
Evaluate the Efficacy and Safety of Brightening Micro-needle Patch on Facial Solar Lentigines
A study testing AIVÍA, Ultra-Brightening Spot Micro-needle Patch in people with Solar Lentigines, run by Panion & BF Biotech Inc. at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Solar Lentigines
- What is being tested?
- AIVÍA, Ultra-Brightening Spot Micro-needle Patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteTaiwan
- Study dates
- 14 Sep 2020to 25 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Dermatology, National Taiwan University
Taipei, 10002
About this study
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
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).
- Conditions
- Solar Lentigines
- Being tested
- AIVÍA, Ultra-Brightening Spot Micro-needle Patch, Placebo Micro-needle Patch
- Keywords
- Solar Lentigines, Micro-needle patch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIVÍA, Ultra-Brightening Spot Micro-needle PatchOther
a dissolving micro-needle patch, contains active ingredients
Placebo Micro-needle PatchOther
matching placebo will be provided as a dissolving micro-needle patch
| Study group | Role | What they receive |
|---|---|---|
| brightening micro-needle patch | Experimental | apply brightening micro-needle patch to one of the two assigned spots on the face according to the instructions on the package Receives: Other: AIVÍA, Ultra-Brightening Spot Micro-needle Patch |
| Placebo | Placebo comparator | apply placebo micro-needle patch to another one of the two assigned spots on the face according to the instructions on the package Receives: Other: Placebo Micro-needle Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 4 week
Secondary outcomes (19)
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)
Measured: 4 week
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)
Measured: 2 week
the value change of melanin index of facial solar lentigines from baseline
measure the melanin index by CK Mexameter at baseline and 2nd week
Measured: 2 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
Measured: 4 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
Measured: 2 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
Measured: 4 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
Measured: 2 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
Measured: 4 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 2nd week
Measured: 2 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
Measured: 4 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
Measured: 2 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
Measured: 4 week
assessing the patches safety on the skin by adverse reactions
assess by the incidence of adverse reactions
Measured: through study completion, an average of 4 weeks
assessing the patches safety on the skin by subject diary
assess by subject diary
Measured: through study completion, an average of 4 weeks
assessing the patches safety on the skin by skin response
assess by skin response score sheets
Measured: through study completion, an average of 4 weeks
assessing the subjects' compliance with the trial by subjects' return visits
assess subjects' compliance by the number of the subjects' return visits
Measured: through study completion, an average of 4 weeks
assessing the subjects' compliance with the trial by subject diary
assess subjects' compliance by subject diary
Measured: through study completion, an average of 4 weeks
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
Measured: through study completion, an average of 4 weeks
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.
Measured: through study completion, an average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start14 Sep 2020
- Primary completion8 Jan 2021
- Study completion25 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solar LentiginesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panion & BF Biotech Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583852
- Sponsor's protocol ID
- PBF-MN-01
- Status last verified
- May 2022
- First submitted
- 10 Sep 2020
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04583852
- Acronym / sponsor ID
- PBF-MN-01
- Conditions
- Solar Lentigines
- Keywords
- Solar Lentigines, Micro-needle patch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Panion & BF Biotech Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2020 (actual)
- Primary completion
- 8 Jan 2021 (actual)
- Study completion
- 25 Jan 2021 (actual)
- First posted
- 12 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| brightening micro-needle patch | Experimental | Other: AIVÍA, Ultra-Brightening Spot Micro-needle Patchapply brightening micro-needle patch to one of the two assigned spots on the face according to the instructions on the package |
| Placebo | Placebo comparator | Other: Placebo Micro-needle Patchapply placebo micro-needle patch to another one of the two assigned spots on the face according to the instructions on the package |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AIVÍA, Ultra-Brightening Spot Micro-needle Patcha dissolving micro-needle patch, contains active ingredients | Other | brightening micro-needle patch |
| Placebo Micro-needle Patchmatching placebo will be provided as a dissolving micro-needle patch | Other | Placebo |
Primary outcome
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)
19 secondary outcomes
the value change of skin tone index ITA° value of facial solar lentigines from baseline
Time frame: 4 week
the value change of skin tone index ITA° value of facial solar lentigines from baseline
Time frame: 2 week
the value change of melanin index of facial solar lentigines from baseline
Time frame: 2 week
the value change of melanin index of facial solar lentigines from baseline
Time frame: 4 week
the percentage change of melanin index of facial solar lentigines from baseline
Time frame: 2 week
the percentage change of melanin index of facial solar lentigines from baseline
Time frame: 4 week
rating the improvement of facial solar lentigines on the facial image taken by VISIA, skin analysis imaging system
Time frame: 2 week
rating the improvement of facial solar lentigines on the facial image taken by VISIA, skin analysis imaging system
Time frame: 4 week
assessing the value change of skin tone index L*a*b* of facial solar lentigines from baseline
Time frame: 2 week
assessing the value change of skin tone index L*a*b* of facial solar lentigines from baseline
Time frame: 4 week
assessing the percentage change of skin tone index L*a*b* of facial solar lentigines from baseline
Time frame: 2 week
assessing the percentage change of skin tone index L*a*b* of facial solar lentigines from baseline
Time frame: 4 week
assessing the patches safety on the skin by adverse reactions
Time frame: through study completion, an average of 4 weeks
assessing the patches safety on the skin by subject diary
Time frame: through study completion, an average of 4 weeks
assessing the patches safety on the skin by skin response
Time frame: through study completion, an average of 4 weeks
assessing the subjects' compliance with the trial by subjects' return visits
Time frame: through study completion, an average of 4 weeks
assessing the subjects' compliance with the trial by subject diary
Time frame: through study completion, an average of 4 weeks
assessing the subjects' compliance with the trial by the number of patches packages returned
Time frame: through study completion, an average of 4 weeks
assessing the subjects' feedback of the patches
Time frame: through study completion, an average of 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
Related trials for Solar Lentigines
Recruiting
A Clinical Study to Evaluate the Efficacy in Improving Dark Spots After 8 Weeks of Use of Facial Sunscreens in Adult Participants
Post-inflammatory Hyperpigmentation, Melasma
Not yet recruiting
Evaluation of Efficacy and Tolerabilty of MelaB3 Serum in Combination of 35% Glycolic Acid Peeling Compared to 35% Glycolic Acid Peeling Alone in Various Hyperpigmentation Conditions
Hyperpigmentation, Melasma
RecruitingObservational study
Melanoma of the Skin and Exposure to Solar Ultraviolet Radiation at Work in Modena Territory: a Case-control Study to Promote an Active Search and Prevention of Occupational Diseases Based on Recent INAIL Criteria
Skin Melanoma, Cutaneous Melanoma
Not yet recruiting
CLINICAL INVESTIGATION TO EVALUATE THE EFFICACY AND SAFETY OF EPILADY PROTOTYPE DEVICE FOLLOWED BY APPLICATION OF A TOPICAL FORMULA ON DEPIGMENTATION OF LENTIGO SPOTS
Solar Lentigo
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AIVÍA, Ultra-Brightening Spot Micro-needle Patch in people with Solar Lentigines, run by Panion & BF Biotech Inc. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percentage change of skin tone index ITA° value of facial solar lentigines from baseline (time frame: 4 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.