Rosacea
Conditions
Interventions
Experimental Group:Oral Black Snake Anti-Itch Pills
Control Group:Oral placebo
Sponsors
South China University of Medical Sciences Dermatology Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1: Meets the diagnostic criteria for rosacea (erythematotelangiectatic type and/or papulopustular type) according to Western medicine (refer to the Chinese Expert Consensus on the Diagnosis and Treatment of Rosacea (2021 edition)). 2: Meets the criteria for TCM syndrome differentiation as "toxic heat leading to blood stasis" (refer to the "Diagnosis and Treatment Standards for TCM Syndromes" by the National Administration of Traditional Chinese Medicine (2012 edition) and the "TCM Surgery" textbook of the 13th Five-Year Plan, 10th edition). 3: Positive detection of Demodex folliculorum in hair follicles. 4: Age: 18-65 years old (inclusive), gender. 5: Lesion severity is mild to moderate, as assessed by the Investigator's Global Assessment (IGA), i.e., IGA score of 2-3. 6: Voluntarily participates in this study and signs the informed consent form.
Exclusion criteria
Exclusion criteria: 1: Patients with other facial skin diseases 2: Patients with severe cardiovascular and cerebrovascular diseases or malignancies 3: Patients with abnormal laboratory indicators: serum creatinine (SCr) exceeding (excluding) the upper limit of normal; alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and gamma-glutamyl transferase (GGT) exceeding (excluding) 1.5 times the upper limit of normal; total bilirubin (TBIL) exceeding (excluding) 1.5 times the upper limit of normal 4: Patients allergic to the investigational drug or its components 5: Patients who are pregnant, breastfeeding, or planning to conceive in the near future 6: Subjects who have used the investigational drug or participated in other clinical trials within the past 3 months prior to screening 7: Subjects deemed unsuitable for participation in the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Paroxysmal Flushing Assessment Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Papule-Pustule Assessment Scale;Rosacea Quality of Life Scale;Itch Visual Analog Scale (VAS) Score;Patient Self-assessment Scale;Symptom Scoring;Hospital Anxiety and Depression Scale;Skin Barrier Function Index;Demodex folliculorum;Physical examination;Vital signs;Laboratory tests;Adverse Event; | — |
Countries
China
Contacts
Public ContactYong Bin Qu
South China University of Medical Sciences Dermatology Hospital
Outcome results
None listed