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A Multicenter Randomized Controlled Trial (RCT) Study on the Clinical Efficacy of Integrated Traditional Chinese and Western Medicine Treatment for Erythematotelangiectatic Rosacea

A Multicenter Randomized Controlled Trial (RCT) on the Clinical Efficacy of Integrated Traditional Chinese and Western Medicine Treatment for Erythematotelangiectatic Rosacea

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001279
Enrollment
Unknown
Registered
2026-05-26
Start date
2025-11-26
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rosacea

Interventions

Control Group:Oral administration of hydroxychloroquine, in combination with narrow-spectrum pulsed light (DPL), and topical application of hyaluronic acid-based cream.
Observation Group A:Oral hydroxychloroquine combined with the traditional Chinese medicine formula Rhino Horn and Rehmannia Decoction, administered alongside topical narrowband intense pulsed light (D
Observation Group B:Oral hydroxychloroquine, traditional Chinese medicine Xijiao Dihuang decoction, combined with narrowband pulsed light (DPL) and intelligent cream of traditional Chinese medicine fo

Sponsors

Wenzhou City Integrated Chinese and Western Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1) Western Medical Diagnostic Criteria 1) According to the Chinese Guideline for the Diagnosis and Treatment of Rosacea (2021 Edition), persistent erythema and hypertrophic changes in the mid-face region that may periodically worsen constitute the two diagnostic features of rosacea. Meeting one or more of these criteria allows for a diagnosis of rosacea; Paroxysmal flushing, papules and/or pustules, telangiectasia, and ocular manifestations (e.g., periorbital telangiectasia, blepharitis, keratitis, conjunctivitis, keratoscleritis) constitute the primary features of rosacea. The presence of two or more primary features suggests a diagnosis of rosacea. 2) Refer to the 2017 American NRSEC rosacea diagnostic classification criteria. Erythematotelangiectatic type: Characterized by mid-facial flushing, persistent erythema with or without telangiectasia, or swelling in the erythematous area. Symptoms significantly worsen with emotional stress, environmental temperature, sun exposure, etc., accompanied by subjective discomfort such as itching, dryness, burning, or stinging. 2) Traditional Chinese Medicine Diagnostic Criteria 1) Refer to the diagnostic criteria for rosacea in the 2010 edition of "Traditional Chinese Medicine Dermatology and Venereology" edited by Fan Ruiqiang et al.: Lung-Stomach Heat Excess Pattern (erythematotelangiectatic phase): Primary symptoms include flushed, persistent erythema on the nose and face; secondary symptoms may include burning sensation, itching, dry mouth and thirst, constipation, yellow tongue coating, and a string-like slippery pulse. 3) Case Inclusion Criteria 1) Age between 18 and 60 years; 2) Patients diagnosed with erythematotelangiectatic rosacea by two dermatologists with over two years of outpatient experience; 3) No major organ diseases (heart, liver, kidney), malignancies, severe infections, other allergic conditions, or autoimmune diseases; normal cognitive and mental status; voluntary participation in this study; 4) No systemic oral use of tetracyclines, isotretinoin, hydroxychloroquine, carvedilol, or similar drugs within the past 4 weeks; 5) No topical application of calcineurin inhibitors, antibiotic ointments, corticosteroids, or herbal ointments with unknown ingredients within the past 2 weeks; 6) No retinal pathologies such as macular degeneration detected by ophthalmic examination; 7) Signed informed consent form, voluntarily enrolled in the study, able to adhere to treatment without interruption, and willing to cooperate closely during treatment observation.

Exclusion criteria

Exclusion criteria: 1) Cases not meeting the aforementioned Western medical diagnostic criteria; 2) Cases under 18 years of age or over 60 years of age; 3) Paroxysmal flushing or persistent erythema caused by other triggers, including topical medications (e.g., corticosteroids, retinoids), systemic medications (e.g., nicotinic acid, isotretinoin), local chemotherapy or phototherapy, menstrual or perimenopausal symptoms, and systemic diseases (e.g., carcinoid syndrome, systemic mastocytosis, medullary carcinoma of certain glands); 4) Concurrent facial dermatitis such as seborrheic dermatitis, facial eczema/atopic dermatitis, acne vulgaris, contact dermatitis, photosensitivity dermatitis, systemic lupus erythematosus, psoriasis, erythematous pemphigus, etc.; 5) Severe primary diseases of the circulatory, digestive, respiratory, hematopoietic, nervous, or endocrine systems with significant symptoms; 6) Individuals with allergic constitutions or a history of allergy to any trial-related medications; 7) History of corticosteroid, immunosuppressant, sedative-hypnotic, or psychotropic medication use within the past month; 8) Individuals with impaired consciousness, psychiatric history, or family history of psychiatric disorders; 9) Smokers or heavy drinkers; 10) Pregnant or lactating women, and women of childbearing age planning pregnancy within the next six months.

Design outcomes

Primary

MeasureTime frame
Skin Lesions and Symptom Scoring Criteria;erythema;

Secondary

MeasureTime frame
Dermatological Medical Image Analysis;The scoring of skin lesions and quality of life in patients.;

Countries

China

Contacts

Public ContactXu Jie

Wenzhou Hospital of Integrative Medicine

xjtdq2002@163.com138 0683 3389

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 11, 2026