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

March 8, 2024 updated by: Weihui Zeng, Second Affiliated Hospital of Xi'an Jiaotong University
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710000
        • The Second Affiliated Hospital of Xi'an Jiaotong Universi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: minocycline treatment group
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 minocycline, 50mg each time, once a day, for 12 weeks.
Experimental: tranilast treatment group
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, 0.1g each time, three times a day, for 12 weeks.
Experimental: 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.
Drug: minocycline
The patient was treated with oral minocycline, 50mg each time, once a day, for 12 weeks.
Drug: tranilast
The patient was treated with oral tranilast, 0.1g each time, three times a day, for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lesion counts
Time Frame: From enrollment to week 12
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.
From enrollment to week 12
Clinician's Erythema Assessment score
Time Frame: From enrollment to week 12
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.
From enrollment to week 12
Global Flushing Severity Scale score
Time Frame: From enrollment to week 12
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.
From enrollment to week 12
Global Acne Grading System score
Time Frame: From enrollment to week 12
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.
From enrollment to week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient satisfaction evaluation
Time Frame: week 12
Patient satisfaction was evaluated as very satisfied, satisfied, relatively satisfied and dissatisfied.
week 12
melanin index
Time Frame: From enrollment to week 12
Use non-invasive skin analyzer to measure the melanin index on the patient's facial skin at each follow-up visit.
From enrollment to week 12
erythema index
Time Frame: From enrollment to week 12
Use non-invasive skin analyzer to measure the erythema index on the patient's facial skin at each follow-up visit.
From enrollment to week 12
transepidermal water loss
Time Frame: From enrollment to week 12
Use non-invasive skin analyzer to measure the transepidermal water loss on the patient's facial skin at each follow-up visit.
From enrollment to week 12
Dermatology Life Quality Index score
Time Frame: week 0 and12
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.
week 0 and12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Xi'an Jiaotong University

Investigators

  • Study Chair: Weihui Zeng, Second Affiliated Hospital of Xi'an JiaoTong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

March 4, 2024

First Submitted That Met QC Criteria

March 8, 2024

First Posted (Actual)

March 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20240301-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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