Efficacy and Safety of Tranilast Combined With Minocycline in the Treatment of Rosacea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE4

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-16

Study Completion Date

2024-06-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rosacea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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minocycline treatment group

The patient was treated with oral minocycline capsules, 50mg each time, once a day, for 12 weeks.

Group Type EXPERIMENTAL

minocycline

Intervention Type DRUG

The patient was treated with oral minocycline, 50mg each time, once a day, for 12 weeks.

tranilast treatment group

The patient was treated with oral tranilast capsules, 0.1g each time, three times a day, for 12 weeks.

Group Type EXPERIMENTAL

tranilast

Intervention Type DRUG

The patient was treated with oral tranilast, 0.1g each time, three times a day, for 12 weeks.

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.

Group Type EXPERIMENTAL

minocycline

Intervention Type DRUG

The patient was treated with oral minocycline, 50mg each time, once a day, for 12 weeks.

tranilast

Intervention Type DRUG

The patient was treated with oral tranilast, 0.1g each time, three times a day, for 12 weeks.

Interventions

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minocycline

The patient was treated with oral minocycline, 50mg each time, once a day, for 12 weeks.

Intervention Type DRUG

tranilast

The patient was treated with oral tranilast, 0.1g each time, three times a day, for 12 weeks.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No