Roller Microneedle Combined with Tranexamic Acid Solution in Treating Melasma

Summary

This article presents a protocol to conduct the treatment of melasma by using roller microneedles in combination with tranexamic acid solution and evaluate the efficacy.

Abstract

Melasma, a common, acquired facial pigmentation skin disorder, presents a straightforward clinical diagnosis but poses challenges in terms of effective management. The precise underlying causes of melasma remain elusive, and the current therapeutic approaches predominantly encompass pharmaceutical and laser interventions, with limited efficacy. Transdermal administration stands as a prevalent treatment method for melasma, often facilitated by the application of microneedles. Among these, tranexamic acid emerges as a frequently employed therapeutic agent. A subset of microneedles, known as roller microneedles, plays a significant role in this approach by delicately puncturing the epidermis with multiple fine needles, synergizing with drug delivery. This methodology not only enhances drug absorption but also augments treatment efficacy while minimizing tissue trauma. These attributes forecast promising avenues for the treatment of melasma. This article primarily introduces the combination of roller microneedle and tranexamic acid solution in the treatment of melasma and demonstrates the efficacy of roller microneedle and tranexamic acid solution in the treatment of melasma through clinical cases.

Introduction

Melasma, also known as chloasma, is a chronic and acquired facial hyperpigmentation skin condition. Clinically, it presents as symmetrical, light to dark brown patches with unclear borders, distributed on the cheeks, forehead, and jawline. The incidence rate among Asian women of childbearing age can be as high as 30%¹. The disease is easily diagnosed but difficult to cure. The pathogenesis of melasma is not yet fully understood, but three main factors contribute to its development: genetic susceptibility, exposure to sunlight, and hormonal changes. Increased melanin synthesis, vascular proliferation at the site of skin lesions, inflammatory reactions, and impaired skin barrier function all play a role in the occurrence of melasma².

Currently, treatment options for melasma include laser therapy and medications, among which, transdermal administration is a widely used method. However, the main challenge lies in the barrier function of the stratum corneum, which hinders drug penetration. Microneedle therapy creates multiple micro-channels in the skin within a short period, disrupting the stratum corneum, inducing collagen production, and increasing skin permeability. This approach holds promise in allowing drugs to diffuse into the skin and then rapidly reseal, thus avoiding the introduction of toxic or irritating substances³.

Commonly used microneedle tools include the electronic water light injection microneedle, roller microneedle, electrically assisted nanocrystalline microneedle, plum blossom microneedle, and single needle microneedle⁴. The roller microneedle is characterized by less trauma, good curative effect, convenient operation, and can be combined with some other drugs to treat melasma. It has a good therapeutic prospect for melasma and is worth more promotion and use in clinical practice. This article introduces the operation and precautions of roller microneedles combined with tranexamic acid in the treatment of melasma and demonstrates the efficacy of roller microneedle combined with tranexamic acid in the treatment of melasma through clinical cases.

Protocol

All research procedures involving human participants comply with the ethical standards of the Ethics Committee of Chongqing Hospital of Traditional Chinese Medicine and the principles of the Declaration of Helsinki (1964) and its subsequent amendments and have received approval for the study from the aforementioned Ethics Committee. Image data collection was performed with both verbal and written consent from the patients, and photographs taken for teaching purposes as a routine part of the examination were obtained using the Multispectral Dermoscope.

1. Patient selection

1. Set the following inclusion criteria⁵:
   1. Select patients based on the presence of facial light to dark brown, well-defined patches, typically with symmetrical distribution, absence of inflammation, and scaling.
   2. Select patients based on the absence of significant subjective symptoms such as itching, burning, and pain.
   3. Select patients considering that melasma predominantly occurs in females, primarily after puberty.
   4. While selecting patients, consider seasonal variations in the condition-often worse in summer and milder in winter.
   5. Exclude patients if other conditions (such as nevus fuscoceruleus zygomaticus, Riehl's melanosis, and pigmentary photodermatitis) that may cause hyperpigmentation are present.

2. Preparation for roller microneedle treatment

1. Preoperative communication
   1. Understand the patient's treatment goals and cosmetic aspirations and gather complete medical history, including medication history, allergies, contraindications, and past cosmetic treatments.
   2. Inform the patients about the treatment's effects, steps, potential complications, recovery time, duration, and costs. Discuss specific treatment plans and alternative options to ensure all patient queries are addressed, helping them establish realistic expectations and achieve higher satisfaction.
   3. Ask patients to sign an informed consent form.
2. Environmental requirements
   1. Set aside a quiet, well-lit treatment room for the operation of the roller microneedle and disinfect it for 30 min with ultraviolet light before the procedure.
   2. Ask the patients to wear shoe covers and hats upon entering the treatment room.
3. Preparation of the necessary items and medication for treatment
   1. Check and prepare all the materials listed in the Table of Materials.
4. Makeup removal and cleansing
   1. If the treatment area was covered with makeup, thoroughly remove it with makeup remover before cleansing.
   2. For non-makeup wearers, clean the treatment area with a gentle cleansing product.
5. Multispectral dermatoscopy recording
   NOTE: The Multispectral dermoscope uses different light sources to capture facial ultra-high pixel images.
   1. Prior to treatments and after three treatments, use the Multispectral dermoscope to take photos of the patient's front, left (45°), and right (45°) from three different angles and record the values of patients' UV-shallow and -deep spots and brown spots
6. Application of topical anesthesia
   1. Apply 5% lidocaine cream evenly to the treated area, with a total dosage of 30-40 g, and wrap it with cling film to enhance the anesthesia effect for 40-60 min.
      NOTE: Some patients may exhibit symptoms of allergy to the topical anesthetic. Patients may experience severe itching, burning, or stinging at the site of application. If such reactions occur, promptly remove the anesthesia and provide appropriate symptomatic treatment.
   2. Before the next treatment, ensure proper moisturization of the skin in the anesthesia application area.
7. Preparation of microneedle solution
   1. Extract 5 mL of 5% tranexamic acid solution using a syringe and set it aside for use.
8. Preparation of microneedle instruments
   1. Select a 0.5 mm roller microneedle (Figure 1) and soak it in 0.1% benzalkonium bromide solution for approximately 20 min to disinfect it.
   2. Rinse the microneedle 3x with physiological saline to remove the disinfectant.
      ​NOTE: Avoid cross-contamination by using a single roller microneedle for each patient to prevent unnecessary damage to the skin due to blunt needles and to prevent the spread of diseases between patients.
9. Removal of topical anesthesia
   1. After a sufficient duration of topical anesthesia application, remove the cling film and scrape off the anesthetic with a spatula. Use gauze soaked in 0.9% saline solution to wipe off any remaining anesthetic from the face.
10. Disinfection
    1. Expose the treatment area, wrap the hair with a disinfectant towel when treating the face, and disinfect the facial skin with a 0.1% benzalkonium bromide cotton ball 3x from the top to the hairline edge, to the lower jaw edge, and chin, following the principle of "bottom-up, inward-outward" to prevent infection.

3. Roller microneedle procedure

1. Have the therapist wash their hands and wear a hat, mask, and sterile gloves.
2. After informing the patient about beginning the procedure, instruct the patient to close their eyes and treat in the order of left cheek, right cheek, forehead, jaw, upper lip, and nose. Inject an appropriate amount of tranexamic acid solution onto the skin using a syringe, apply evenly by hand, and then rinse the roller microneedle with physiological saline, roll it in a short distance along the horizontal, vertical, and oblique directions in the treatment area.
3. Gradually perform the treatment in different areas, applying the solution while rolling to enhance absorption. Repeat 3-5x in one area, preferably with skin flushing and no obvious bleeding. Apply force evenly, neither too heavy nor too light, and do not drag a microneedle on the skin.

4. Efficacy evaluation

1. Use a combination of roller microneedles and topical tranexamic acid solution 3x for the treatment of melasma, once every 4 weeks, as a course of treatment.
2. Use the multispectral dermatoscope before and after treatment, 3x to observe the efficacy according to the values of the patients' UV shallow and deep spots and brown spots. The smaller the values, the lighter the melasma.
3. Statistically analyze the changes in the UV-shallow and -deep spots and brown spots before and after treatment.

Results

Case 1, a 57-year-old female with a medical history of 10 years, was selected for treatment and efficacy evaluation. The efficacy of the combination of roller microneedle and tranexamic acid solution was evaluated before treatment and after three treatment sessions (Figure 2, Figure 3, and Figure 4) and observed from different angles using a multispectral dermatoscope. A reduction of 35.91 mm², 163.32 mm², and ...

Discussion

The pathogenesis of melasma is complex, and treatment methods include systemic medication, topical depigmenting agents, chemical peels, and laser therapy. Unfortunately, no single treatment is universally effective for all patients, and satisfactory results cannot be always guaranteed⁶. Phototherapy shows a decreasing trend in treating melasma, and some patients experience worsening of melasma after phototherapy. This is due to an increase in individuals with sensitive skin and impaired skin barri...

Materials

Name	Company	Catalog Number	Comments
5 mL syringe
Benzalkonium bromide solution	Chongqing Traditional Chinese Medicine Hospital	H20050531	0.1%
cling film
Compound lidocaine cream	Beijing Ziguang Pharmaceutical Co., Ltd.	H20063466	5.0%
disinfectant towel
disposable curved disc
Multispectral Dermoscope	CBS Medical Skin Analysis, Wuhan, China	CBS-2022
Roller microneedle	Guangzhou Yuanxiang Biotechnology Co., Ltd	221001	(model: 0.22 x 0.5 mm, Figure 1)
Sodium chloride solution	Hubei Tiansheng Pharmaceutical Co., Ltd.	H42021838	0.9%
sterile cotton swab
sterile gauze
sterile gloves
tongue depressor
Tranexamic acid solution	Shanghai Hyundai Hasen (Shangqiu) Pharmaceutical Co., Ltd.	H20184047	5.0%
treatment vehicle