NCT04583852

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Panion & BF Biotech Inc. · Industry
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

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).

Conditions

• Solar Lentigines

Interventions

Type	Name	Description
OTHER	AIVÍA, Ultra-Brightening Spot Micro-needle Patch	a dissolving micro-needle patch, contains active ingredients
OTHER	Placebo Micro-needle Patch	matching placebo will be provided as a dissolving micro-needle patch

Timeline

• Start date: 2020-09-14
• Primary completion: 2021-01-08
• Completion: 2021-01-25
• First posted: 2020-10-12
• Last updated: 2022-05-24

Locations

1 site across 1 country: Taiwan