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Oral Tranexamic Acid Treatment For Blushing Rosacea Patients Enhances Skin Barrier

Oral Tranexamic Acid Treatment For Blushing Rosacea Patients Enhances Skin Barrier

Overview

Papulopustular rosacea (PPR) presents a persistent challenge due to its chronic nature and the substantial impact it has on facial appearance and patient well-being. Central to the pathogenesis of PPR is an impaired skin barrier, which not only exacerbates the inflammatory process but also compromises the skin’s ability to retain moisture and protect against environmental aggressors. This compromised barrier function not only contributes to the development and progression of PPR but also makes traditional treatment approaches less effective in managing the condition.

 

Tranexamic acid (TXA) emerges as a promising therapeutic agent for PPR due to its multifaceted pharmacological properties. Beyond its well-known role in hemostasis, tranexamic acid exhibits immune regulatory and anti-inflammatory effects, modulating key pathways involved in the pathogenesis of rosacea. Furthermore, TXA demonstrates the ability to inhibit angiogenesis and endothelial hyperplasia, processes that contribute to the persistent erythema and telangiectasia characteristic of rosacea. Additionally, tranexamic acid promotes skin barrier repair by enhancing epidermal cell proliferation and extracellular matrix synthesis, thereby reinforcing the skin’s natural defense mechanisms.

 

In our study, we sought to investigate the efficacy and safety of oral tranexamic acid supplementation as an adjunctive therapy for PPR. The inclusion of tranexamic acid in the treatment regimen was hypothesized to address not only the inflammatory component of PPR but also the underlying barrier dysfunction, thereby offering comprehensive relief for patients. To rigorously evaluate the therapeutic impact of tranexamic acid , we conducted a randomized controlled trial involving 70 patients, comparing traditional therapy alone to traditional therapy supplemented with oral tranexamic acid over an 8-week intervention period, followed by a 4-week observation phase.

 

Our comprehensive assessment encompassed both subjective and objective measures to capture the full spectrum of treatment outcomes. Subjective evaluations included clinical assessments such as the clinical erythema assessment (CEA), investigator’s global assessment (IGA), patient self-assessment (PSA) score, and rosacea-specific quality of life (RQoL) score, as well as a global aesthetic improvement score (GAIS) to gauge overall satisfaction with treatment outcomes. Objective measurements focused on parameters indicative of skin barrier function, including skin hydration and trans-epidermal water loss (TEWL), supplemented by clinical photography and advanced imaging techniques to provide a comprehensive evaluation of treatment response.

 

Our results revealed significant improvements across multiple domains in patients receiving oral tranexamic acid supplementation, including reductions in erythema, papules, and pustules, as well as improvements in dryness and overall quality of life. Importantly, the addition of TXA was associated with enhanced skin barrier function, as evidenced by increased skin hydration and reduced TEWL, indicating a restoration of the skin’s protective capacity. Notably, these benefits were achieved without significant adverse effects, highlighting the safety profile of oral tranexamic acid in the management of PPR.

 

Furthermore, subgroup analysis revealed differential treatment responses based on the clinical subtype of rosacea, with patients exhibiting dry-type rosacea experiencing greater improvements in skin barrier function compared to those with oily skin. This observation underscores the importance of tailoring treatment approaches to the individual characteristics of each patient, thereby optimizing therapeutic outcomes.

 

In conclusion, our study provides compelling evidence for the efficacy and safety of oral tranexamic acid supplementation as an adjunctive therapy for PPR. By addressing both the inflammatory and barrier dysfunction components of the condition, tranexamic acid offers a holistic approach to PPR management, resulting in rapid and sustainable improvements in symptoms and quality of life. These findings not only expand our therapeutic armamentarium for PPR but also pave the way for personalized treatment strategies that prioritize the restoration of skin barrier function, thereby improving long-term outcomes for patients with this challenging condition.

Introduction

Papulopustular rosacea (PPR) stands out as a prevalent concern among individuals newly diagnosed with rosacea, significantly impacting facial aesthetics. Symptoms commonly include persistent erythema, flushing, along with discomfort such as burning, itching, and dryness, all of which can detrimentally affect a patient’s quality of life. Despite its prevalence, clinical treatment of PPR remains challenging. While doxycycline (40 mg/day) stands as the sole FDA-approved antibiotic, its efficacy often falls short of satisfactory outcomes. Hence, there’s a pressing need to establish a model for developing more effective treatment approaches.

 

The compromised skin barrier emerges as a critical factor in both the onset and aggravation of rosacea. Research indicates that individuals with rosacea exhibit elevated trans-epidermal water loss (TEWL) and reduced skin hydration levels, underscoring a heightened degree of skin barrier impairment compared to those without the condition. Moreover, genetic predispositions, innate immune dysfunctions, and neurovascular irregularities are linked to rosacea development.

 

Tranexamic acid (TXA) emerges as a promising candidate for treatment, given its immune regulatory and anti-inflammatory properties, along with its capacity to inhibit angiogenesis, endothelial hyperplasia, and promote skin barrier restoration. This randomized controlled clinical trial aims to assess the efficacy and safety of oral tranexamic acid treatment in PPR patients, followed by a post-treatment evaluation one month later. The study also investigates TXA’s impact on objective skin barrier indicators such as TEWL and skin hydration, correlating these findings with clinical erythema assessment (CEA) and investigator’s global assessment (IGA).

 

Furthermore, considering the Baumann skin typing system’s insights, which suggest oily skin types are more predisposed to rosacea development and less likely to achieve remission, our analysis includes an examination of the correlation between skin barrier improvement and dry versus oily skin types in the Baumann classification. This holistic approach aims to shed light on the multifaceted dynamics of PPR treatment, integrating clinical efficacy with objective skin barrier metrics and individual skin characteristics for comprehensive patient care.

Method

A prospective, randomized study was conducted at the Second Affiliated Hospital of Xi’an Jiaotong University in China from April to August 2023, with approval from the Institutional Review Board and adherence to the Helsinki Declaration. 158 patients meeting specific criteria were screened, with 82 eventually enrolled. Participants were randomly assigned to either receive traditional treatment alone or traditional treatment along with tranexamic acid (TXA). The tranexamic acid group received oral tranexamic acid , doxycycline, and hyaluronic acid lotion, while the traditional treatment group received only doxycycline and hyaluronic acid lotion. Evaluations were conducted at various intervals, assessing factors such as skin characteristics, clinical scores, and quality of life. The primary endpoint was improvement in the Clinical Erythema Assessment (CEA) score at week 8, with a predefined criterion for superiority of tranexamic acid treatment effectiveness. Safety assessments included monitoring liver and kidney function, as well as coagulation-related parameters. The study prohibited concurrent use of other rosacea treatments to isolate the effects of the interventions.

Statistical Analysis

The study’s statistical methodology was meticulously planned to ensure robust analysis and reliable results. Based on predetermined assumptions regarding the efficacy rates in the control and experimental groups, along with an estimated dropout rate, a sample size of 35 patients per group was determined. This sample size was calculated to provide a high statistical power of at least 85%, allowing for the detection of significant differences in the primary endpoint with a two-sided significance level of 0.05.

 

Various statistical tests, including the Student’s t-test, Mann–Whitney U test, Fisher test, z-test, and Spearman’s correlation analyses, were employed as appropriate for the type and distribution of the data. Data analysis was conducted using SPSS 18.0, a widely recognized software for statistical analysis.

 

To maintain data integrity, patients with missing data were excluded from the analysis. Additionally, sensitivity analyses were conducted in cases where the amount of missing data exceeded 5%. These meticulous steps were taken to ensure the accuracy and reliability of the study findings, adhering to rigorous scientific standards.

Result

Certainly. This study provides comprehensive insights into the efficacy and safety of tranexamic acid (TXA) treatment compared to traditional therapies for rosacea management. Rosacea, a chronic inflammatory skin condition, poses significant challenges in its treatment due to its varied clinical manifestations and potential impact on patients’ quality of life.

 

The trial enrolled 70 patients, primarily females with a median duration of rosacea of 3 years, ensuring a representative sample from the north-western region of China. The demographic characteristics between the tranexamic acid and traditional treatment groups were well-balanced, enhancing the study’s reliability and reducing confounding factors.

 

TXA treatment demonstrated remarkable superiority over traditional therapies in reducing erythema and disease severity, as assessed by Clinical Erythema Assessment (CEA) and Investigator Global Assessment (IGA) scores. Notably, the tranexamic acid group exhibited more substantial and rapid improvements, underscoring its potential as a promising therapeutic option for rosacea management.

 

Moreover, TXA treatment exhibited significant benefits in enhancing skin barrier function, particularly in improving skin hydration and reducing Transepidermal Water Loss (TEWL). These improvements were closely correlated with reductions in CEA grade, highlighting the pivotal role of skin barrier integrity in mitigating erythema severity and overall disease progression in rosacea patients.

 

Furthermore, subgroup analysis based on Baumann’s skin typing classification revealed that TXA treatment was particularly effective for patients with dry skin, leading to significant improvements in CEA grade, skin hydration, and TEWL. This nuanced understanding of TXA’s differential effects based on skin type provides valuable clinical insights and underscores the importance of personalized treatment approaches in rosacea management.

 

Importantly, TXA treatment exhibited a favorable safety profile, with minimal adverse events reported and no cases of recurrence observed during the study period. This finding underscores the potential of TXA as a well-tolerated and safe therapeutic option for rosacea patients, further supporting its clinical utility in diverse patient populations.

 

In summary, this study contributes significant evidence supporting the efficacy and safety of TXA treatment in rosacea management, particularly in improving erythema severity, enhancing skin barrier function, and minimizing adverse events. These findings hold implications for optimizing therapeutic strategies and improving outcomes for rosacea patients, paving the way for further research and clinical implementation of TXA in dermatological practice.

Conclusion

Research indicates that Tranexamic Acid (TXA) shows promise in managing rosacea by reducing inflammation and suppressing key factors involved in its pathogenesis. TXA effectively reduces neutrophils, inhibits CD4+ T-cell infiltration, and blocks the peptide LL-37-induced inflammation, resulting in anti-inflammatory effects. Additionally, tranexamic acid treatment suppresses the production of Toll-like receptor 2 (TLR2), cytokines, and chemokines in keratinocytes, further mitigating inflammation. It also decreases the expression of endothelin-1 and tumor necrosis factor-alpha, partially inhibits angiogenesis, and regulates serine protease activity, all contributing to its therapeutic effects on rosacea.

 

While topical tranexamic acid has been explored, it may hinder wound healing in minor injuries, making oral TXA a preferable option, especially for patients with numerous facial epidermal injuries characteristic of papulopustular rosacea (PPR). Oral TXA minimizes skin irritation by avoiding direct contact with affected areas, although further research is needed to elucidate its underlying mechanisms.

 

TXA’s ability to inhibit increased serine protease activity and promote the release of lamellar bodies aids in restoring the skin barrier function, potentially shortening rosacea treatment duration and enhancing efficacy. Compared to traditional treatments, TXA demonstrates superior outcomes in improving itchiness, dryness, and skin barrier status, thereby enhancing patients’ quality of life without significant adverse effects.

 

Moreover, TXA’s ability to reduce melanin production aligns with aesthetic preferences for fair skin, particularly in East Asian populations. Its targeted effects on specific mechanisms suggest personalized treatment approaches based on skin type, offering novel insights for refining rosacea management strategies.

 

While doxycycline is an FDA-approved treatment for rosacea, its oral administration entails various side effects, unlike oral tranexamic acid , which primarily presents with thrombotic risks and minor discomforts. Nonetheless, caution is advised regarding potential interactions with other medications and long-term safety, particularly concerning its approval for melasma treatment in Japan and China.

 

Despite limitations such as small sample size and regional focus, this study underscores TXA’s potential as a viable treatment option for rosacea, particularly facial erythema. Further research is needed to establish optimal dosing regimens for diverse populations, thereby alleviating the substantial economic burden associated with rosacea management.

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