Papulopustular rosacea
Conditions
Interventions
1.5% CKBA cream group:1.5% CKBA ointment (2FTU, BID)
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 to 85 (inclusive), of either gender; 2. Diagnosed with moderate to severe papulopustular rosacea, with the following facial characteristics: 15 to 70 facial papules and pustules, excluding lesions on the eyes and scalp; no more than 2 nodules on the face; IGA score of moderate (3) or severe (4); 3. Willing to avoid factors that the researcher believes may trigger rosacea outbreaks; 4. Adhere to all lifestyle regulations outlined in the study protocol throughout the entire duration; 5. The subject or their legal guardian voluntarily signs an informed consent form approved by the ethics committee.
Exclusion criteria
Exclusion criteria: 1. Subjects with significant worsening of rosacea symptoms within 4 weeks prior to screening, which researchers deemed difficult to assess stably; 2. Subjects with other skin diseases that may interfere with the assessment of rosacea at the time of screening, including but not limited to: psoriasis, acne vulgaris, seborrheic dermatitis, steroid-dependent dermatitis, eczema, sebaceous gland hyperplasia, contact dermatitis, cosmetic-induced skin damage, vitiligo/patchy leukoplakia, pigmentation diseases such as chloasma, active bacterial folliculitis, and facial skin or hair conditions that interfere with clinical assessment (such as beards, sideburns, mustaches, etc.); 3. Subjects with moderate to severe nasal hypertrophy (hypertrophic hypertrophy type), severe erythematous telangiectasia rosacea (CEA score of 4), and facial plaque-like edema at the time of screening; 4. Subjects with significant dryness/keratolysis and severe itching/burning sensation at the time of screening; 5. Subjects who have undergone cosmetic surgery (such as facial care) within 2 weeks prior to screening that may affect the efficacy and safety of the study drug; 6. Subjects who have used skincare products with acne-fighting effects evaluated by researchers within 1 week prior to screening, including but not limited to: salicylic acid, glycolic acid, azelaic acid, tranexamic acid, aloe vera leaf extract, witch hazel extract, licorice extract, centella asiatica extract, purslane extract, etc.; 7. Subjects who have used topical treatments for rosacea within 2 weeks prior to screening, such as topical antibiotics, metronidazole/ivermectin/azelaic acid, retinoids, benzoyl peroxide, corticosteroids, immunosuppressants, biologics, etc.; 8. Subjects who have received systemic treatment such as immunosuppressants, anti-inflammatory drugs, antibiotics within 4 weeks prior to screening; 9. Subjects who have undergone phototherapy, chemical peeling, laser treatment, or other physical therapies (such as intense pulsed light) within 8 weeks prior to screening; 10. Subjects with acute bacterial, fungal, or viral skin infections (such as herpes simplex, herpes zoster, varicella) within 4 weeks prior to screening; 11. Subjects with severe local infections (such as cellulitis, abscess) or systemic infections (such as pneumonia, sepsis) within 12 weeks prior to screening, requiring intravenous anti-infective treatment or hospitalization due to infection; 12. Subjects with severe active autoimmune diseases such as systemic lupus erythematosus, acquired immune deficiency syndrome, and receiving immunosuppressant treatment due to autoimmune diseases at the time of screening; 13. Subjects with a history or symptoms suggesting active tuberculosis at the time of screening; 14. Subjects with a history of malignant tumors within 5 years prior to screening; 15. Subjects with a history of psychiatric disorders within 2 years prior to screening; 16. Subjects with the following cardiovascular and cerebrovascular diseases within 6 months prior to screening: moderate to severe congestive heart failure (New York Heart Association class III or IV), unstable angina pectoris, myocardial infarction, severe arrhythmia, coronary stent implantation, cerebrovascular accident (cerebral infarction or cerebral hemorrhage), deep vein thrombosis, pulmonary embolism, recurrent asthma attacks, etc., with hypertension poorly controlled despite active treatment (systolic blood pressure > 160 mmHg o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At 16 weeks of treatment, the change in inflammatory lesion count (ILC) compared to baseline;AI At 16 weeks of treatment, the proportion of subjects with an Investigator's Global Assessment (IGA) score of 0 or 1; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in ILC compared to baseline at 4, 8, and 12 weeks of treatment;The proportion of subjects with IGA scores of 0 or 1 at 4, 8, and 12 weeks of treatment;Percentage of change value of ILC compared to baseline at 4, 8, 12, and 16 weeks of treatment;The proportion of subjects with an improvement of 2 points or more in IGA score at 4, 8, 12, and 16 weeks of treatment;The proportion of subjects with Clinical Erythema Assessment (CEA) scores of 0 or 1 at 4, 8, 12, and 16 weeks of treatment;The proportion of subjects with a 2-point or more improvement in CEA score at 4, 8, 12, and 16 weeks of treatment;The proportion of subjects with Patient Self-Assessment (PSA) scores of 0 or 1 at 4, 8, 12, and 16 weeks of treatment;The proportion of subjects with a 2-point or greater improvement in PSA score at 4, 8, 12, and 16 weeks of treatment;Changes in Global Flushing Severity Scale (GFSS) scores compared to baseline at 4, 8, 12, and 16 weeks of treatment;Changes in the Rosacea Quality of Life Scale (RosaQoL) scores compared to baseline at 12 and 16 weeks of treatment;Changes in Hospital Anxiety and Depression Scale (HADS) scores compared to baseline at 12 and 16 weeks of treatment;Treatment-Emergent Adverse Event (TEAE);Serious Adverse Event (SAE);Physical examination, vital signs measurement, 12-lead electrocardiogram (ECG), and clinical laboratory tests;Assessment of local skin tolerance; | — |
Countries
China
Contacts
Public ContactXian Jiang
West China Hospital, Sichuan University
Outcome results
None listed