This work was financially supported by the Key Project of Medical Research Jointly from Chongqing Health Commission and Chongqing Science and Technology Bureau (2022ZDXM037), the Key Projects of Scientific Research Fund of Traditional Chinese Medicine of Wuhan Health Commission (WZ22A03), and Natural Science Foundation of Chongqing (cstc2020jcyj-msxmX0592).

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
<ol>
	<li>Set the following inclusion criteria5:
	<ol>
		<li>Select patients based on the presence of facial light to dark brown, well-defined patches, typically with symmetrical distribution, absence of inflammation, and scaling.</li>
		<li>Select patients based on the absence of significant subjective symptoms such as itching, burning, and pain.</li>
		<li>Select patients considering that melasma predominantly occurs in females, primarily after puberty.</li>
		<li>While selecting patients, consider seasonal variations in the condition-often worse in summer and milder in winter.</li>
		<li>Exclude patients if other conditions (such as nevus fuscoceruleus zygomaticus, Riehl&#39;s melanosis, and pigmentary photodermatitis) that may cause hyperpigmentation are present.</li>
	</ol>
	</li>
</ol>
2. Preparation for roller microneedle treatment
<ol>
	<li>Preoperative communication
	<ol>
		<li>Understand the patient&#39;s treatment goals and cosmetic aspirations and gather complete medical history, including medication history, allergies, contraindications, and past cosmetic treatments.</li>
		<li>Inform the patients about the treatment&#39;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.</li>
		<li>Ask patients to sign an informed consent form.</li>
	</ol>
	</li>
	<li>Environmental requirements
	<ol>
		<li>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.</li>
		<li>Ask the patients to wear shoe covers and hats upon entering the treatment room.</li>
	</ol>
	</li>
	<li>Preparation of the necessary items and medication for treatment
	<ol>
		<li>Check and prepare all the materials listed in the Table of Materials.</li>
	</ol>
	</li>
	<li>Makeup removal and cleansing
	<ol>
		<li>If the treatment area was covered with makeup, thoroughly remove it with makeup remover before cleansing.</li>
		<li>For non-makeup wearers, clean the treatment area with a gentle cleansing product.</li>
	</ol>
	</li>
	<li>Multispectral dermatoscopy recording 
	NOTE: The Multispectral dermoscope uses different light sources to capture facial ultra-high pixel images.
	<ol>
		<li>Prior to treatments and after three treatments, use the Multispectral dermoscope to take photos of the patient&#39;s front, left (45&#176;), and right (45&#176;) from three different angles and record the values of patients&#39; UV-shallow and -deep spots and brown spots</li>
	</ol>
	</li>
	<li>Application of topical anesthesia
	<ol>
		<li>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.</li>
		<li>Before the next treatment, ensure proper moisturization of the skin in the anesthesia application area.</li>
	</ol>
	</li>
	<li>Preparation of microneedle solution
	<ol>
		<li>Extract 5 mL of 5% tranexamic acid solution using a syringe and set it aside for use.</li>
	</ol>
	</li>
	<li>Preparation of microneedle instruments
	<ol>
		<li>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.</li>
		<li>Rinse the microneedle 3x with physiological saline to remove the disinfectant. 
		&#8203;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.</li>
	</ol>
	</li>
	<li>Removal of topical anesthesia
	<ol>
		<li>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.</li>
	</ol>
	</li>
	<li>Disinfection
	<ol>
		<li>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 &#34;bottom-up, inward-outward&#34; to prevent infection.</li>
	</ol>
	</li>
</ol>
3. Roller microneedle procedure
<ol>
	<li>Have the therapist wash their hands and wear a hat, mask, and sterile gloves.</li>
	<li>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.</li>
	<li>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.</li>
</ol>
4. Efficacy evaluation
<ol>
	<li>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.</li>
	<li>Use the multispectral dermatoscope before and after treatment, 3x to observe the efficacy according to the values of the patients&#39; UV shallow and deep spots and brown spots. The smaller the values, the lighter the melasma.</li>
	<li>Statistically analyze the changes in the UV-shallow and -deep spots and brown spots before and after treatment.</li>
</ol>

Enhancing Melasma Treatment with Tranexamic Acid and Microneedling Therapy

<ol>
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Consensus on diagnosis and treatment of melasma in China (2021 vision).</a> Chinese Journal Dermatology. 54 (2), 110-115 (2021).</li><li>Vineet, K. R., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Microneedle+arrays+for+cutaneous+and+transcutaneous+drug+delivery,+disease+diagnosis,+and+cosmetic+aid.">Microneedle arrays for cutaneous and transcutaneous drug delivery, disease diagnosis, and cosmetic aid.</a> Journal of Drug Delivery Science and Technology. 79, 104058 (2023).</li><li>Skin Laser Medical Aesthetics Group, Dermatology and Venereology Branch, Chinese Medical Association, Skin Laser Technology Application Research Center of the Chinese Medical Association. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Chinese+dermatologists'+consensus+on+laser+and+IPLS+treatment+and+skin+repairment+of+melasma.">Chinese dermatologists' consensus on laser and IPLS treatment and skin repairment of melasma.</a> Journal Practical Dermatology. 13 (2), 65-69 (2020).</li><li>Pigment Disease Group. Dermatovenereology Professional Committee of Chinese Society of Integrative Medicine. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Clinical+diagnosis+and+efficacy+criteria+for+melasma+(revised+in+2003).">Clinical diagnosis and efficacy criteria for melasma (revised in 2003).</a> Chinese Journal of Dermatology Venereology Integrative Traditional and Western Medicine. 3 (1), 66 (2004).</li><li>McKesey, J., Tovar-Garza, A., Pandya, A. G. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Melasma+treatment:+an+evidence-based+review.">Melasma treatment: an evidence-based review.</a> American Journal of Clinical Dermatology. 21 (2), 173-225 (2020).</li><li>Budamakuntla, L., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=A+randomised,+open-label,+comparative+study+of+tranexamic+acid+microinjections+and+tranexamic+acid+with+microneedling+in+patients+with+melasma.">A randomised, open-label, comparative study of tranexamic acid microinjections and tranexamic acid with microneedling in patients with melasma.</a> Journal of Cutaneous and Aesthetic Surgery. 6 (3), 139-143 (2013).</li><li>Cohen, B. E., Elbuluk, N. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Microneedling+in+skin+of+color:+a+review+of+uses+and+efficacy.">Microneedling in skin of color: a review of uses and efficacy.</a> Journal of the American Academy of Dermatology. 74 (2), 348-355 (2016).</li><li>Lee, H. C., Thng, T. G. S., Goh, C. L. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Oral+tranexamic+acid+(TA)+in+the+treatment+of+melasma:+a+retrospective+analysis.">Oral tranexamic acid (TA) in the treatment of melasma: a retrospective analysis.</a> Journal of the American Academy of Dermatology. 75 (2), 385-392 (2016).</li><li>Banihashemi, M., Zabolinejad, N., Jaafari, M. R., Salehi, M., Jabari, A. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Comparison+of+therapeutic+effects+of+liposomal+tranexamic+acid+and+conventional+hydroquinone+on+melasma.">Comparison of therapeutic effects of liposomal tranexamic acid and conventional hydroquinone on melasma.</a> Journal of Cosmetic Dermatology. 14 (3), 174-177 (2015).</li><li>Ebrahimi, B., Naeini, F. F. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Topical+tranexamic+acid+as+a+promising+treatment+for+melasma.">Topical tranexamic acid as a promising treatment for melasma.</a> Journal of Research in Medical Sciences. 19 (8), 753-757 (2014).</li><li>Na, J. I., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Effect+of+tranexamic+acid+on+melasma:+a+clinical+trial+with+histological+evaluation.">Effect of tranexamic acid on melasma: a clinical trial with histological evaluation.</a> Journal of the European Academy of Dermatology and Venereology. 27 (8), 1035-1039 (2013).</li><li>Kim, E. H., Kim, Y. C., Lee, E. S., Kang, H. Y. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=The+vascular+characteristics+of+melasma.">The vascular characteristics of melasma.</a> Journal of Dermatological Science. 46 (2), 111-116 (2007).</li><li>Yuan, C., Wang, X. M., Yang, L. J., Wu, P. L. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Tranexamic+acid+accelerates+skin+barrier+recovery+and+upregulates+occluding+in+damaged+skin.">Tranexamic acid accelerates skin barrier recovery and upregulates occluding in damaged skin.</a> International Journal of Dermatology. 53 (8), 959-965 (2014).</li><li>Tohgasaki, T., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Enolase-1+expression+in+the+stratum+corneum+is+elevated+with+parakeratosis+of+atopic+dermatitis+and+disrupts+the+cellular+tight+junction+barrier+in+keratinocytes.">Enolase-1 expression in the stratum corneum is elevated with parakeratosis of atopic dermatitis and disrupts the cellular tight junction barrier in keratinocytes.</a> International Journal of Cosmetic Science. 40 (2), 178-186 (2018).</li><li>Lima, E. V. A., Lima, M. M. D. A., Paix&#227;o, M. P., Miot, H. A. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Assessment+of+the+effects+of+skin+microneedling+as+adjuvant+therapy+for+facial+melasma:+a+pilot+study.">Assessment of the effects of skin microneedling as adjuvant therapy for facial melasma: a pilot study.</a> BMC Dermatology. 17 (1), 14 (2017).</li><li>Saleh, F., Abdel-Azim, E., Ragaie, M., Guendy, M. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Topical+tranexamic+acid+with+microneedling+versus+microneedling+alone+in+treatment+of+melasma:+clinical,+histopathologic,+and+immunohistochemical+study.">Topical tranexamic acid with microneedling versus microneedling alone in treatment of melasma: clinical, histopathologic, and immunohistochemical study.</a> Journal of Egypt Women's Dermatologic Society. 16 (2), 89 (2019).</li><li>Bailey, A. J. M., Li, H. O., Tan, M. G., Cheng, W., Dover, J. S. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Microneedling+as+an+adjuvant+to+topical+therapies+for+melasma:+A+systematic+review+and+meta-analysis.">Microneedling as an adjuvant to topical therapies for melasma: A systematic review and meta-analysis.</a> Journal of the American Academy of Dermatology. 86 (4), 797-810 (2022).</li></ol>

The authors have no conflicts of interest to declare.

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...

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.

<table border="1" fo:keep-together.within-page="1" fo:keep-with-next.within-page="always">
	<tbody>
		<tr>
			<td>5 mL syringe</td>
			<td></td>
			<td></td>
			<td></td>
		</tr>
		<tr>
			<td>Benzalkonium bromide solution</td>
			<td>Chongqing Traditional Chinese Medicine Hospital</td>
			<td>H20050531</td>
			<td>0.1%</td>
		</tr>
		<tr>
			<td>cling film</td>
			<td></td>
			<td></td>
			<td></td>
		</tr>
		<tr>
			<td>Compound lidocaine cream</td>
			<td>Beijing Ziguang Pharmaceutical Co., Ltd.</td>
			<td>H20063466</td>
			<td>5.0%</td>
		</tr>
		<tr>
			<td>disinfectant towel</td>
			<td></td>
			<td></td>
			<td></td>
		</tr>
		<tr>
			<td>disposable curved disc</td>
			<td></td>
			<td></td>
			<td></td>
		</tr>
		<tr>
			<td>Multispectral Dermoscope</td>
			<td>CBS Medical Skin Analysis, Wuhan, China</td>
			<td>CBS-2022</td>
			<td></td>
		</tr>
		<tr>
			<td>Roller microneedle</td>
			<td>Guangzhou Yuanxiang Biotechnology Co., Ltd</td>
			<td>221001</td>
			<td>(model: 0.22 x 0.5 mm, Figure 1)</td>
		</tr>
		<tr>
			<td>Sodium chloride solution</td>
			<td>Hubei Tiansheng Pharmaceutical Co., Ltd.</td>
			<td>H42021838</td>
			<td>0.9%</td>
		</tr>
		<tr>
			<td>sterile cotton swab</td>
			<td></td>
			<td></td>
			<td></td>
		</tr>
		<tr>
			<td>sterile gauze</td>
			<td></td>
			<td></td>
			<td></td>
		</tr>
		<tr>
			<td>sterile gloves</td>
			<td></td>
			<td></td>
			<td></td>
		</tr>
		<tr>
			<td>tongue depressor</td>
			<td></td>
			<td></td>
			<td></td>
		</tr>
		<tr>
			<td>Tranexamic acid solution</td>
			<td>Shanghai Hyundai Hasen (Shangqiu) Pharmaceutical Co., Ltd.</td>
			<td>H20184047</td>
			<td>5.0%</td>
		</tr>
		<tr>
			<td>treatment vehicle</td>
			<td></td>
			<td></td>
			<td></td>
		</tr>
	</tbody>
</table>

roller microneedle combined with tranexamic acid solution in treating melasma

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.

Author Spotlight: Non-Surgical Treatment of Melasma&amp;#8211; Microneedling with Tranexamic Acid

Roller Microneedle Combined with Tranexamic Acid Solution in Treating Melasma

Our research focus on non-surgery therapy for pigmentated disease. We tested the efficacy of roller microneedling combined with tranexamic acid solution in treating melasma. We will investigate the effectiveness and the max easiness of using a combination of roller microneedles and tranexamic acid solution for treating melasma.

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 ...

Watch this Scientific Journal Video about Roller Microneedle Combined with Tranexamic Acid Solution in Treating Melasma at JoVE.com

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.

Melasma, a common, acquired facial pigmentation skin disorder, presents a straightforward clinical diagnosis but poses challenges in terms of effective ...

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705 Views.  Chongqing Hospital of Traditional Chinese Medicine. La nostra ricerca si concentra sulla terapia non chirurgica per la malattia pigmentata. Abbiamo testato l'efficacia del microneedling a rullo combinato con una soluzione di acido tranexamico nel trattamento del melasma. Studieremo l'efficacia e la massima facilità di utilizzo di una combinazione di microaghi a rullo e soluzione di acido tranexamico per il trattamento del melasma.