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.
233 studies on the registry are indexed under Rosacea; 23 are open to participants now.
This study's planned enrollment of 45 is below the median of 61 across 200 interventional studies indexed under Rosacea.
Browse Rosacea studies →Second Affiliated Hospital of Xi'an Jiaotong University is the lead sponsor of 70 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Started Oct 2023 (actual). Primary completion is estimated for Jun 2024, 7 months after the start.
Of 12 phase 4 interventional studies under Rosacea, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 21. This study's planned 7 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Minocycline · Tranilast
Second Affiliated Hospital of Xi'an Jiaotong University