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Clinical Development and Evaluation of a Multi-Component Dissolving Microneedle Patch for Skin Pigmentation Disorders
Chenxin Yan1,2, Mengzhen Xing3, Suohui Zhang1,4
1Key Laboratory of Photochemical Conversion and Optoelectronic Materials, Technical Institute of Physics and Chemistry, Chinese Academy of Sciences, Beijing 100190, China.
Polymers
|August 12, 2023
Summary
This study developed dissolving microneedles (DMNs) loaded with a combination of glabridin, 3-O-ethyl-L-ascorbic acid, and tranexamic acid to treat skin pigmentation. The DMNs effectively reduced melanin production and improved conditions like chloasma and age spots.
Area of Science:
- Dermatology
- Materials Science
- Pharmacology
Background:
- Excessive melanin deposition causes skin pigmentation diseases like chloasma and age spots.
- Tyrosinase activity and oxidative stress are key factors in melanin overproduction.
- Current topical treatments face challenges with skin permeability.
Purpose of the Study:
- To develop a multi-component, multi-pathway drug combination for skin depigmentation.
- To create dissolving microneedles (DMNs) for enhanced delivery of the drug combination.
- To evaluate the efficacy and safety of the DMNs for treating hyperpigmentation.
Main Methods:
- Formulation of a drug combination including glabridin (tyrosinase inhibitor), 3-O-ethyl-L-ascorbic acid (antioxidant), and tranexamic acid (melanin transmission inhibitor).
- Fabrication of dissolving microneedles using hyaluronic acid, poly(vinyl alcohol), and poly(vinylpyrrolidone) to encapsulate the drug combination.
- In vitro testing for skin insertion, dissolution, drug delivery, antioxidant activity, and tyrosinase inhibition.
- In vitro and in vivo studies using melanoma cells (B16-F10) and zebrafish to assess melanin production reduction.
- Clinical evaluation of DMN safety and efficacy in reducing chloasma and age spots.
Main Results:
- The developed DMNs demonstrated excellent skin insertion, dissolution, and drug delivery capabilities.
- In vitro experiments confirmed significant antioxidant effects and tyrosinase inhibition by the drug-loaded DMNs.
- Melanin production was effectively reduced in both melanoma cells and zebrafish models.
- Clinical studies confirmed the safety of the DMNs and their significant efficacy in reducing chloasma and age spots.
Conclusions:
- A multi-component, multi-pathway drug combination delivered via dissolving microneedles offers a promising approach for skin depigmentation.
- The developed DMNs provide a safe and effective method for treating hyperpigmentation disorders like chloasma and age spots.
- This complex DMN formulation represents a valuable product for clinical application in managing skin pigmentation issues.
