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

Rosacea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06307288
• Other study ID #: 20240301-2
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: October 16, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: March 2024
• Source: Second Affiliated Hospital of Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 45
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rosacea

Intervention

Drug:
• minocycline
The patient was treated with oral minocycline, 50mg each time, once a day, for 12 weeks.
• tranilast
The patient was treated with oral tranilast, 0.1g each time, three times a day, for 12 weeks.

Locations

Country	Name	City	State
China	The Second Affiliated Hospital of Xi'an Jiaotong Universi	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

References & Publications (7)

Aroni K, Tsagroni E, Kavantzas N, Patsouris E, Ioannidis E. A study of the pathogenesis of rosacea: how angiogenesis and mast cells may participate in a complex multifactorial process. Arch Dermatol Res. 2008 Mar;300(3):125-31. doi: 10.1007/s00403-007-081 — View Citation

Del Rosso JQ, Webster G, Weiss JS, Bhatia ND, Gold LS, Kircik L. Nonantibiotic Properties of Tetracyclines in Rosacea and Their Clinical Implications. J Clin Aesthet Dermatol. 2021 Aug;14(8):14-21. Epub 2021 Aug 1. — View Citation

Marchitto MC, Chien AL. Mast Cell Stabilizers in the Treatment of Rosacea: A Review of Existing and Emerging Therapies. Dermatol Ther (Heidelb). 2021 Oct;11(5):1541-1549. doi: 10.1007/s13555-021-00597-7. Epub 2021 Sep 2. — View Citation

Schaller M, Almeida LM, Bewley A, Cribier B, Dlova NC, Kautz G, Mannis M, Oon HH, Rajagopalan M, Steinhoff M, Thiboutot D, Troielli P, Webster G, Wu Y, van Zuuren E, Tan J. Rosacea treatment update: recommendations from the global ROSacea COnsensus (ROSCO — View Citation

Schaller M, Almeida LMC, Bewley A, Cribier B, Del Rosso J, Dlova NC, Gallo RL, Granstein RD, Kautz G, Mannis MJ, Micali G, Oon HH, Rajagopalan M, Steinhoff M, Tanghetti E, Thiboutot D, Troielli P, Webster G, Zierhut M, van Zuuren EJ, Tan J. Recommendation — View Citation

Tan J, Almeida LM, Bewley A, Cribier B, Dlova NC, Gallo R, Kautz G, Mannis M, Oon HH, Rajagopalan M, Steinhoff M, Thiboutot D, Troielli P, Webster G, Wu Y, van Zuuren EJ, Schaller M. Updating the diagnosis, classification and assessment of rosacea: recomm — View Citation

Wozniak E, Owczarczyk-Saczonek A, Lange M, Czarny J, Wygonowska E, Placek W, Nedoszytko B. The Role of Mast Cells in the Induction and Maintenance of Inflammation in Selected Skin Diseases. Int J Mol Sci. 2023 Apr 10;24(8):7021. doi: 10.3390/ijms24087021. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From enrollment to week 12
Primary	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.	From enrollment to week 12
Primary	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.	From enrollment to week 12
Primary	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.	From enrollment to week 12
Secondary	patient satisfaction evaluation	Patient satisfaction was evaluated as very satisfied, satisfied, relatively satisfied and dissatisfied.	week 12
Secondary	melanin index	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
Secondary	erythema index	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
Secondary	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.	From enrollment to week 12
Secondary	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.	week 0 and12