A Phase 4 interventional study of minocycline and tranilast in Rosacea, sponsored by Second Affiliated Hospital of Xi'an Jiaotong University. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-03-12.
Sponsored by Second Affiliated Hospital of Xi'an Jiaotong University · Phase 4, Interventional, and Treatment
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.
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.
Exclusion Criteria:
The patient was treated with oral minocycline capsules, 50mg each time, once a day, for 12 weeks.
Drug: minocycline
The patient was treated with oral tranilast capsules, 0.1g each time, three times a day, for 12 weeks.
Drug: 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.
Drug: minocycline · Drug: tranilast
The patient was treated with oral minocycline, 50mg each time, once a day, for 12 weeks.
The patient was treated with oral tranilast, 0.1g each time, three times a day, for 12 weeks.
lesion counts
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.
Time frame: From enrollment to week 12
Clinician's Erythema Assessment score
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.
Time frame: From enrollment to week 12
Global Flushing Severity Scale score
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.
Time frame: From enrollment to week 12
Global Acne Grading System score
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.
Time frame: From enrollment to week 12
patient satisfaction evaluation
Patient satisfaction was evaluated as very satisfied, satisfied, relatively satisfied and dissatisfied.
Time frame: week 12
melanin index
Use non-invasive skin analyzer to measure the melanin index on the patient's facial skin at each follow-up visit.
Time frame: From enrollment to week 12
erythema index
Use non-invasive skin analyzer to measure the erythema index on the patient's facial skin at each follow-up visit.
Time frame: From enrollment to week 12
transepidermal water loss
Use non-invasive skin analyzer to measure the transepidermal water loss on the patient's facial skin at each follow-up visit.
Time frame: From enrollment to week 12
Dermatology Life Quality Index score
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.
Time frame: week 0 and12
Plan to share: No
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Second Affiliated Hospital of Xi'an Jiaotong University