Efficacy and Safety of Tranilast Combined With Minocycline in the Treatment of Rosacea
- Registration Number
- NCT06307288
- Lead Sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 45
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description tranilast treatment group tranilast The patient was treated with oral tranilast capsules, 0.1g each time, three times a day, for 12 weeks. minocycline treatment group minocycline The patient was treated with oral minocycline capsules, 50mg each time, once a day, for 12 weeks. tranilast combined with minocycline treatment group tranilast 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. tranilast combined with minocycline treatment group minocycline 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.
- Primary Outcome Measures
Name Time Method lesion counts 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 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 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 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.
- Secondary Outcome Measures
Name Time Method patient satisfaction evaluation week 12 Patient satisfaction was evaluated as very satisfied, satisfied, relatively satisfied and dissatisfied.
melanin index From enrollment to week 12 Use non-invasive skin analyzer to measure the melanin index on the patient's facial skin at each follow-up visit.
erythema index From enrollment to week 12 Use non-invasive skin analyzer to measure the erythema index on the patient's facial skin at each follow-up visit.
Dermatology Life Quality Index score week 0 and12 The name of the scale is Dermatology Life Quality Index. It was used to assess the changes in quality of life before and after treatment. The Dermatology Life Quality Index score ranges from 0 to 29, with higher scores indicating a greater impact of the disease on the patient's quality of life.
transepidermal water loss From enrollment to week 12 Use non-invasive skin analyzer to measure the transepidermal water loss on the patient's facial skin at each follow-up visit.
Trial Locations
- Locations (1)
The Second Affiliated Hospital of Xi'an Jiaotong Universi
🇨🇳Xi'an, Shaanxi, China