Efficacy, Safety, Satisfaction, Adherence to Treatment With Nano-Formulated Cysteamine Tranexamic Acid Cream to Treat Melasma

July 2024 | Volume 23 | Issue 7 | 529 | Copyright © July 2024


Published online June 12, 2024

doi:10.36849/JDD.7765R1

Khalil A. Khatri MDa, Nurul Ain Abdullah MDb, Steve Chia MDc, Edmond Ng MDd, Nazelia Thibroni MDe

aSkin & Laser Surgery Center of New England, Boston, MA
bAlainn Clinic, Kuala Lumpur, Malaysia 
cSliq Clinic, Kuala Lumpur, Malaysia 
dXeoul Clinic, UCSI University, Kuala Lumpur, Malaysia
eDr. Nazelia Clinic, Kuala Lumpur, Malaysia 

Abstract
Background: Melasma is a chronic pigmentary disorder. In this study, an innovative cream combining cysteamine and tranexamic acid (TXA) was assessed.
Objective: To evaluate the safety, efficacy, and patient satisfaction of a novel nano-formulated cysteamine and TXA combination cream in treating subjects with epidermal melasma.
Methods:  Fifty (50) randomized subjects participated and received cysteamine and TXA combination cream. The cream was applied for 30 minutes daily for a 3-month duration. Treatment effectiveness, safety, patient satisfaction, and adherence were evaluated.
Results: A continuous improvement in melasma was observed, with modified Melasma Area and Severity Index (mMASI) scores improving by 40%, 57%, and 63% at 30, 60, and 90 days, respectively. The primary endpoint of a decrease in mMASI scores was met, with 91% of participants experiencing melasma improvement. Patient Satisfaction and Patient Adherence scores indicated satisfaction. Convenience exhibited the strongest correlation with patient adherence. 
Conclusion: Nano-formulated cysteamine and TXA combination cream showed significant efficacy in decreasing mMASI score while demonstrating a strong safety profile and patient satisfaction. 

J Drugs Dermatol. 2024;23(7):529-537.     doi:10.36849/JDD.7765R1

INTRODUCTION

Melasma is an acquired pigmentary condition primarily affecting sun-exposed skin. The pathogenesis of melasma remains unknown, encompassing genetic factors, sun exposure, hormonal contraceptives, photosensitizing drugs, skin inflammation, and stress.1 

The appearance of melasma can significantly impact self-esteem and social life. Melasma is more prevalent among East Asian, Middle Eastern, and Mediterranean-African populations and intertropical regions in the Americas, predominantly in female gender.

Current treatments focus on eliminating potential causative factors and diligently using sunscreen.2 Other methods include topical hypo-pigmenting agents, chemical peels, laser therapy, oral TXA, and administration of vitamins C and E. Intravenous injection of vitamin C or glutathione is also practiced in some countries.3 Additionally, selected phenolic compounds exhibit protective effects against UV-related skin damage.

Cysteamine hydrochloride (beta-mercaptoethylamine hydro-chloride), a potent depigmenting molecule, is the simplest stable aminothiol, naturally produced in the human body as an L-cysteine degradation product. Cysteamine is a well-tolerated, non-carcinogenic compound. However, undesirable properties of cysteamine, such as unpleasant odor, chemical instability, hygroscopicity, and poor pharmacokinetic profile, limit its use.4,5 

TXA, a synthetic derivative of the amino acid lysine, is a well-established antifibrinolytic agent. In addition, recent studies have revealed that TXA may also possess depigmenting properties, making it a potential candidate for treating melasma.6,7,11 

In previous research, cysteamine and TXA creams have proven effective for melasma. However, those studies either utilized cysteamine or TXA creams. We used a novel cysteamine and TXA formula in a cream, utilizing a nano-encapsulation system. We used mMASI, a 9-item Patient Satisfaction Questionnaire