Clinical trial NCT04583852: 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
Overall status: COMPLETED
Phase: NA
Conditions: Solar Lentigines
Keywords: Solar Lentigines
Micro-needle patch
Lead sponsor: Panion & BF Biotech Inc.
Sponsor class: INDUSTRY
First posted: 2020-10-12
Enrollment: 35
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

Eligibility 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.

Primary outcomes:
measure: the percentage change of skin tone index ITA° value of facial solar lentigines from baseline
timeFrame: 4 week
Secondary outcomes:
measure: the value change of skin tone index ITA° value of facial solar lentigines from baseline
timeFrame: 4 week
measure: the value change of skin tone index ITA° value of facial solar lentigines from baseline
timeFrame: 2 week
measure: the value change of melanin index of facial solar lentigines from baseline
timeFrame: 2 week
measure: the value change of melanin index of facial solar lentigines from baseline
timeFrame: 4 week
measure: the percentage change of melanin index of facial solar lentigines from baseline
timeFrame: 2 week
measure: the percentage change of melanin index of facial solar lentigines from baseline
timeFrame: 4 week
measure: rating the improvement of facial solar lentigines on the facial image taken by VISIA, skin analysis imaging system
timeFrame: 2 week
measure: rating the improvement of facial solar lentigines on the facial image taken by VISIA, skin analysis imaging system
timeFrame: 4 week
measure: assessing the value change of skin tone index L*a*b* of facial solar lentigines from baseline
timeFrame: 2 week
measure: assessing the value change of skin tone index L*a*b* of facial solar lentigines from baseline
timeFrame: 4 week
measure: assessing the percentage change of skin tone index L*a*b* of facial solar lentigines from baseline
timeFrame: 2 week
measure: assessing the percentage change of skin tone index L*a*b* of facial solar lentigines from baseline
timeFrame: 4 week
measure: assessing the patches safety on the skin by adverse reactions
timeFrame: through study completion, an average of 4 weeks
measure: assessing the patches safety on the skin by subject diary
timeFrame: through study completion, an average of 4 weeks
measure: assessing the patches safety on the skin by skin response
timeFrame: through study completion, an average of 4 weeks
measure: assessing the subjects' compliance with the trial by subjects' return visits
timeFrame: through study completion, an average of 4 weeks
measure: assessing the subjects' compliance with the trial by subject diary
timeFrame: through study completion, an average of 4 weeks
measure: assessing the subjects' compliance with the trial by the number of patches packages returned
timeFrame: through study completion, an average of 4 weeks
measure: assessing the subjects' feedback of the patches
timeFrame: through study completion, an average of 4 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Dermatology, National Taiwan University
Study officials:
References: