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The efficacy and safety of anti-inflammation treatment (Hirudoid introduction followed by yellow light therapy) combined with tofacitinib and doxycycline in Chinese adult patients with mild to moderate erythematous telangiectatic rosacea: A prospective parallel controlled single-blind cohort study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Participants receive doxycycline combined with hydroxychloroquine. |
|
| Tofacitinib group | Active Comparator | Participants receive doxycycline combined with tofacitinib. |
|
| Anti-inflammation Treatment and Tofacitinib group | Experimental | Participants receive doxycycline and tofacitinib combined with anti-inflammatory treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doxycycline | Drug | Doxycycline 100 mg orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of IGA treatment success at Week 12 | Achievement of IGA treatment success(IGA = 0 or 1, and the proportion of subjects with an improvement of ≥2 grades from baseline) at Week 12 | 0 week、12 week |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects achieving successful IGA treatment | The proportion of subjects achieving successful IGA treatment (IGA = 0 or 1, and the proportion of subjects with an improvement of ≥2 grades from baseline) | From baseline to weeks 4, 8, and 12 |
| Dermatology Life Quality Index(DLQI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liu | Contact | 0579-89979999 | 2197055@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fourth Affiliated Hospital of Zhejiang University School of Medicine | Recruiting | Yiwu | Zhejiang | 322000 | China |
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| Hydroxychloroquine | Drug | Hydroxychloroquine 200 mg orally twice daily. |
|
| Tofacitinib | Drug | Tofacitinib 5mg orally twice daily. |
|
| Anti-inflammatory Treatment (Hirudoid Introduction Followed by Yellow Light Therapy) | Device | Topical application of Hirudoid followed by yellow light therapy (wavelength 590 nm, duration 20 minutes per session, once weekly) |
|
Patient questionnaire, score is calculated between 0 (worst score possible) and 30 (best score possible) |
| Baseline, week 12 |
| Change in facial erythema severity assessed by VISIA imaging system | Facial erythema severity will be quantitatively assessed using the VISIA imaging system. Standardized facial photographs will be obtained at each visit, and changes in erythema severity from baseline will be evaluated using VISIA-derived analysis. | From baseline to weeks 4, 8, and 12 |
| ID | Term |
|---|---|
| D012393 | Rosacea |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D004318 | Doxycycline |
| D006886 | Hydroxychloroquine |
| C479163 | tofacitinib |
| ID | Term |
|---|---|
| D013754 | Tetracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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