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

NCT06307288 | Enrolling By Invitation Phase 4

• 1 other identifier: 20240301-2
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rosacea

Keywords

rosacea; mast cell stabilizers; tranilast; minocycline; treatment; clinical research

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (5)

• patient satisfaction evaluation

  week 12

• melanin index

  From enrollment to week 12

• erythema index

  From enrollment to week 12

• transepidermal water loss

  From enrollment to week 12

• Dermatology Life Quality Index score

  week 0 and12

Study Arms (3)

minocycline treatment group

EXPERIMENTAL

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

Drug: minocycline

tranilast treatment group

EXPERIMENTAL

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

Drug: tranilast

tranilast combined with minocycline treatment group

EXPERIMENTAL

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

Interventions

minocycline DRUG

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

minocycline treatment group; tranilast combined with minocycline treatment group

tranilast 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; tranilast treatment group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Males and nonpregnant females, aged 18-60 years old;
• Diagnosed with erythematotelangiectatic or papulopustular rosacea, with an investigator' s global assessment of 3-5;
• Patients with good cognitive function and normal mental status;
• Patients with good communication skills;
• Voluntary participation in the study and signing of informed consent form.

You may not qualify if:

• Allergy to any component of tranilast capsules;
• Allergy to any component of minocycline capsules;
• History of systemic medication for rosacea treatment within the past month;
• Pregnancy or lactation;
• 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.

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead

Study Sites (1)

The Second Affiliated Hospital of Xi'an Jiaotong Universi

Xi'an, Shaanxi, 710000, China

Location

Related Publications (7)

• 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.

  PMID: 34476755 RESULT

• 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/s00403-007-0816-z. Epub 2007 Dec 11.

  PMID: 18071725 RESULT

• 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.

  PMID: 37108184 RESULT

• 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.

  PMID: 34840653 RESULT

• 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. Recommendations for rosacea diagnosis, classification and management: update from the global ROSacea COnsensus 2019 panel. Br J Dermatol. 2020 May;182(5):1269-1276. doi: 10.1111/bjd.18420. Epub 2019 Oct 16.

  PMID: 31392722 RESULT

• 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: recommendations from the global ROSacea COnsensus (ROSCO) panel. Br J Dermatol. 2017 Feb;176(2):431-438. doi: 10.1111/bjd.15122. Epub 2017 Jan 23.

  PMID: 27718519 RESULT

• 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) panel. Br J Dermatol. 2017 Feb;176(2):465-471. doi: 10.1111/bjd.15173. Epub 2017 Feb 5.

  PMID: 27861741 RESULT

MeSH Terms

Conditions

Rosacea; cyclopia sequence

Interventions

Minocycline; tranilast

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Weihui Zeng

  Second Affiliated Hospital of Xi'an Jiaotong University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: October 16, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)