Efficacy and Safety of Tranilast Combined With Minocycline in the Treatment of Rosacea
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- lesion counts
研究概览
简要总结
Rosacea is a chronic inflammatory skin disease with a complex pathogenesis involving multiple factors. Currently, the treatment of rosacea remains highly challenging. Mast cells, as key participants in the pathogenesis of rosacea, have been shown to alleviate rosacea symptoms with some topical, oral, and injectable mast cell stabilizers in recent years. Tranilast stabilizes mast cells and basophils by acting on their cell membranes and preventing their degranulation. Tranilast has been used in the treatment of various skin disease, such as hypertrophic scars and atopic dermatitis. Minocycline is a first-line treatment for rosacea, and low-dose minocycline treatment (50mg/day) is believed to have anti-inflammatory effects without antibacterial effects, thus minimizing the dysbiosis and bacterial resistance caused by antibiotic use. Therefore, this study aims to investigate the effectiveness and safety of combining mast cell stabilizer tranilast with low-dose minocycline treatment for rosacea, providing new treatment options and insights for rosacea patients.
详细描述
Rosacea is a chronic inflammatory skin disease with a complex pathogenesis involving multiple factors. Currently, the treatment of rosacea remains highly challenging. In the skin, mast cells are located in the dermis near nerve endings and blood vessels, playing a crucial role in inflammatory responses. Mast cells, as key participants in the pathogenesis of rosacea, have been shown to alleviate rosacea symptoms with some topical, oral, and injectable mast cell stabilizers in recent years. Tranilast stabilizes mast cells and basophils by acting on their cell membranes and preventing their degranulation. Tranilast has been used in the treatment of various skin disease, such as hypertrophic scars and atopic dermatitis. Minocycline is a first-line treatment for rosacea, and low-dose minocycline treatment (50mg/day) is believed to have anti-inflammatory effects without antibacterial effects, thus minimizing the dysbiosis and bacterial resistance caused by antibiotic use. However, there is currently a lack of clinical studies evaluating the efficacy and safety of combined treatment with tranilast and minocycline for rosacea. Therefore, this study aims to investigate the effectiveness and safety of combining mast cell stabilizer tranilast with low-dose minocycline treatment for rosacea, providing new treatment options and insights for rosacea patients.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and nonpregnant females, aged 18-60 years old;
- •Diagnosed with erythematotelangiectatic or papulopustular rosacea, with an investigator' s global assessment of 3-5;
- •Patients with good cognitive function and normal mental status;
- •Patients with good communication skills;
- •Voluntary participation in the study and signing of informed consent form.
排除标准
- •Allergy to any component of tranilast capsules;
- •Allergy to any component of minocycline capsules;
- •History of systemic medication for rosacea treatment within the past month;
- •Pregnancy or lactation;
- •Presence of severe primary diseases in addition to rosacea, such as cardiovascular system, cerebrovascular system, digestive system, urinary system, hematopoietic system diseases, or systemic failure.
研究组 & 干预措施
minocycline treatment group
The patient was treated with oral minocycline capsules, 50mg each time, once a day, for 12 weeks.
干预措施: minocycline (Drug)
tranilast treatment group
The patient was treated with oral tranilast capsules, 0.1g each time, three times a day, for 12 weeks.
干预措施: tranilast (Drug)
tranilast combined with minocycline treatment group
The patient was treated with oral tranilast capsules, 0.1g each time, three times a day; oral minocycline capsules, 50mg each time, once a day, for 12 weeks.
干预措施: minocycline (Drug)
tranilast combined with minocycline treatment group
The patient was treated with oral tranilast capsules, 0.1g each time, three times a day; oral minocycline capsules, 50mg each time, once a day, for 12 weeks.
干预措施: tranilast (Drug)
结局指标
主要结局
lesion counts
时间窗: From enrollment to week 12
The counts of skin lesions, including papules, pustules, and papulopustules, was used to evaluate the changes of facial inflammatory skin lesions before and after treatment.
Clinician's Erythema Assessment score
时间窗: From enrollment to week 12
The name of the scale is Clinician's Erythema Assessment. It was used to evaluate the change of persistent facial erythema before and after treatment. The score on the Clinician's Erythema Assessment scale ranges from 0 to 9, with higher scores indicating more severe persistent erythema on the patient's face.
Global Acne Grading System score
时间窗: From enrollment to week 12
The name of the scale is Global Acne Grading System. It was used to evaluate the changes of facial inflammatory skin lesions before and after treatment. The Global Acne Grading System score ranges from 0 to 32, with higher scores indicating more inflammatory lesions on the patient's face.
Global Flushing Severity Scale score
时间窗: From enrollment to week 12
The name of the scale is Global Flushing Severity Scale. It was used to evaluate the change of facial flushing symptoms before and after treatment. The score on the Global Flushing Severity Scale ranges from 0 to 10, with higher scores indicating more severe symptoms of facial flushing.
次要结局
- patient satisfaction evaluation(week 12)
- melanin index(From enrollment to week 12)
- erythema index(From enrollment to week 12)
- Dermatology Life Quality Index score(week 0 and12)
- transepidermal water loss(From enrollment to week 12)
研究者
Weihui Zeng
Professor
Second Affiliated Hospital of Xi'an Jiaotong University