Clinical trial NCT06307288: Efficacy and Safety of Tranilast Combined With Minocycline in the Treatment of Rosacea
Official title: Efficacy and Safety of Tranilast Combined With Minocycline in the Treatment of Rosacea
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Rosacea
Keywords: rosacea
mast cell stabilizers
tranilast
minocycline
treatment
clinical research
Lead sponsor: Second Affiliated Hospital of Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: lesion counts
timeFrame: From enrollment to week 12
measure: Clinician's Erythema Assessment score
timeFrame: From enrollment to week 12
measure: Global Flushing Severity Scale score
timeFrame: From enrollment to week 12
measure: Global Acne Grading System score
timeFrame: From enrollment to week 12
Secondary outcomes:
measure: patient satisfaction evaluation
timeFrame: week 12
measure: melanin index
timeFrame: From enrollment to week 12
measure: erythema index
timeFrame: From enrollment to week 12
measure: transepidermal water loss
timeFrame: From enrollment to week 12
measure: Dermatology Life Quality Index score
timeFrame: week 0 and12
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong Universi
state: Shaanxi
Study officials:
affiliation: Second Affiliated Hospital of Xi'an Jiaotong University
name: Weihui Zeng
role: STUDY_CHAIR
References:
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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.
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.
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. 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.
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: 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.
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) panel. Br J Dermatol. 2017 Feb;176(2):465-471. doi: 10.1111/bjd.15173. Epub 2017 Feb 5.