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

NCT04583852 | Completed DMC

• 1 other identifier: PBF-MN-01
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Solar Lentigines

Keywords

Solar Lentigines; Micro-needle patch

Outcome Measures

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)

  4 week

Secondary Outcomes (19)

• the value change of skin tone index ITA° value of facial solar lentigines from baseline

  4 week

• the value change of skin tone index ITA° value of facial solar lentigines from baseline

  2 week

• the value change of melanin index of facial solar lentigines from baseline

  2 week

• the value change of melanin index of facial solar lentigines from baseline

  4 week

• the percentage change of melanin index of facial solar lentigines from baseline

  2 week

Study Arms (2)

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

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

Other: Placebo Micro-needle Patch

Interventions

AIVÍA, Ultra-Brightening Spot Micro-needle Patch OTHER

a dissolving micro-needle patch, contains active ingredients

brightening micro-needle patch

Placebo Micro-needle Patch OTHER

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

Placebo

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Panion & BF Biotech Inc.: lead

Study Sites (1)

Department of Dermatology, National Taiwan University

Taipei, 10002, Taiwan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: October 12, 2020
• Study Start: September 14, 2020
• Primary Completion: January 8, 2021
• Study Completion: January 25, 2021
• Last Updated: May 24, 2022

Record last verified: 2022-05

Locations

TW (1)