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

Xi'an Jiaotong University

Status and phase: Invitation-only; Phase 4

Conditions: Rosacea

Treatments: Drug: minocycline; Drug: tranilast

Study type: Interventional

Funder types: Other

Identifiers

NCT06307288

20240301-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

minocycline treatment group

Experimental group

Description:

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

Treatment:

Drug: minocycline

tranilast treatment group

Experimental group

Description:

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

Treatment:

Drug: tranilast

tranilast combined with minocycline treatment group

Experimental group

Description:

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.

Treatment:

Drug: tranilast

Drug: minocycline