Effectiveness of Oral Melatonin vs Oral Tranexamic Acid in the Treatment and Recurrence of Melasma : A Comparative, Randomized, Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Change in modified Melasma Area and Severity Index (mMASI)
研究概览
简要总结
This study compares the effectiveness of two oral medications-melatonin and tranexamic acid -in treating melasma, a common skin condition that causes dark facial patches.
Participants will be randomly assigned to receive either melatonin, tranexamic acid, or a placebo once daily at bedtime for 12 weeks. During this treatment phase, all participants will also apply a broad-spectrum sunscreen and a base cream.
After 12 weeks, participants will stop the oral medication but continue using the sunscreen and base cream for an additional 12 weeks to assess recurrence of melasma.
The study evaluates improvement in skin pigmentation, recurrence after treatment cessation, quality of life, and patient satisfaction.
This clinical trial will be conducted at Benchakitti Park Hospital, Bangkok, Thailand, and will enroll 75 adult participants.
详细描述
Melasma is a chronic skin disorder characterized by symmetrical, hyperpigmented patches on sun-exposed areas, especially the face. Although its exact cause is not fully understood, hormonal influences, ultraviolet (UV) exposure, and genetic predisposition are contributing factors.
Tranexamic acid (TXA), an antifibrinolytic agent, has shown promising results in treating melasma by inhibiting melanogenesis through the plasminogen-plasmin pathway. Melatonin (MLT), a hormone with antioxidant and anti-inflammatory properties, has also demonstrated potential benefits in melasma management by reducing oxidative stress and interfering with the melanin synthesis pathway.
This prospective, randomized, controlled, evaluator-blinded clinical trial aims to compare the efficacy and recurrence outcomes of oral TXA (500 mg), oral MLT (2 mg), and placebo, each administered once daily for 12 weeks. After discontinuing the oral treatment, all participants will continue using sunscreen and base cream for an additional 12 weeks to evaluate recurrence.
Outcome measures include modified Melasma Area and Severity Index (mMASI), Mexameter-based pigmentation indices, quality of life scores (DLQI), and patient satisfaction (VAS). The study is conducted at Benchakitti Park Hospital and includes 75 adult participants with epidermal or mixed-type melasma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with the age above 18 years and above
- •Patients diagnosed with epidermal or mixed-type melasma
排除标准
- •Use of topical medications such as hydroquinone, whitening agents (e.g., arbutin, kojic acid, vitamin C, retinoids, and steroids) on melasma areas within 4 weeks prior to joining the study
- •Chemical peeling within 4 weeks prior to joining the study
- •Use of oral tranexamic acid or any supplements within 3 months prior to joining the study
- •History of laser treatment, dermabrasion, or skin-tightening devices within 6 months prior to joining the study
- •History of botulinum toxin injections, fillers, collagen stimulators, or thread lifts within 12 months prior to joining the study
- •Pregnancy or breastfeeding
- •Use of hormonal contraceptives within 1 year prior to joining the study
- •Personal or family history of thrombotic disorders, such as deep vein thrombosis, pulmonary embolism, stroke, protein C or S deficiency, or antithrombin III deficiency
- •History of more than 2 spontaneous abortion
- •History of impaired kidney function
- •History of cancer
- •Heart disease (e.g., end-stage heart failure, chronic obstructive pulmonary disease, or use of prosthetic heart valves)
- •History of allergy to oral tranexamic acid or melatonin
- •Patients who are unable to follow up as per the study protocol
- •Patients with Hori's nevus
研究组 & 干预措施
Tranexamic Acid (TXA)
Participants will receive 500 mg of oral tranexamic acid (Transamin®) once daily at bedtime for 12 weeks, along with a broad-spectrum sunscreen and a base cream.
干预措施: Tranexamic Acid (TXA) (Drug)
melatonin (Circadin)
Participants will receive 2 mg of oral melatonin (Circadin®) once daily at bedtime for 12 weeks, along with a broad-spectrum sunscreen and a base cream.
干预措施: melatonin (Circadin) (Drug)
Placebo
Participants will receive a placebo capsule once daily at bedtime for 12 weeks, along with a broad-spectrum sunscreen and a base cream.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in modified Melasma Area and Severity Index (mMASI)
时间窗: Baseline, Week 4, Week 8, Week 12
Change in modified Melasma Area and Severity Index (mMASI) score from baseline to Week 12. The mMASI ranges from 0 to 14.4, with higher scores indicating more severe melasma.
Change in modified Melasma Area and Severity Index (mMASI) (Recurrence)
时间窗: Week 12, Week 16, Week 20, Week 24
Recurrence is defined as an increase in mMASI score ≥50% from Week 12 to Week 24. The mMASI ranges from 0 to 14.4; higher scores indicate worse melasma.
次要结局
- Melanin and Erythema Index(Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24)
- Change in skin texture, pore size, fine line (Antera 3D imaging)(Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24)
- Dermatology Life Quality Index (DLQI) score(Baseline, Week 12, Week 24)
- Patient satisfaction (Visual Analog Scale)(Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24)
- Adverse events (AEs)(Week 4, Week 8, Week 12)
研究者
Premjit Juntongjin, MD
Associate Professor, Principal Investigator
Thammasat University