Clinical trial
Efficacy and Safety of Tranilast Combined With Minocycline in the Treatment of Rosacea
Name
20240301-2
Description
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.
Trial arms
Trial start
2023-10-16
Estimated PCD
2024-06-01
Trial end
2024-06-01
Phase
Early phase I
Treatment
minocycline
The patient was treated with oral minocycline, 50mg each time, once a day, for 12 weeks.
Arms:
minocycline treatment group, tranilast combined with minocycline treatment group
tranilast
The patient was treated with oral tranilast, 0.1g each time, three times a day, for 12 weeks.
Arms:
tranilast combined with minocycline treatment group, tranilast treatment group
Size
45
Primary endpoint
lesion counts
From enrollment to week 12
Clinician's Erythema Assessment score
From enrollment to week 12
Global Flushing Severity Scale score
From enrollment to week 12
Global Acne Grading System score
From enrollment to week 12
Eligibility criteria
Inclusion Criteria:
1. Males and nonpregnant females, aged 18-60 years old;
2. Diagnosed with erythematotelangiectatic or papulopustular rosacea, with an investigator' s global assessment of 3-5;
3. Patients with good cognitive function and normal mental status;
4. Patients with good communication skills;
5. Voluntary participation in the study and signing of informed consent form.
Exclusion Criteria:
1. Allergy to any component of tranilast capsules;
2. Allergy to any component of minocycline capsules;
3. History of systemic medication for rosacea treatment within the past month;
4. Pregnancy or lactation;
5. 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 45, 'type': 'ESTIMATED'}}
Updated at
2024-03-12
1 organization
2 products
1 indication
Product
minocyclineIndication
Acne RosaceaProduct
tranilast