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| Name | Class |
|---|---|
| Beijing Friendship Hospital | OTHER |
| LanZhou University | OTHER |
| The First Hospital of Hebei Medical University | OTHER |
| Xingtai People's Hospital |
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The study was designed to collect information over 1800 patients with a clinical diagnosis of subacute or chronic eczema, these patients' prescriptions contain Hirudoid®. EASI, IGA and more indicators are evaluated. Data were collected for a maximum of 12 weeks according to the clinician's consultation and follow-up (Time points were set at baseline, 1, 2, 3, 4, 8 and 12 weekends). The above data were analysed to explore the optimal treatment modality, dose and treatment period for patients with subacute or chronic eczema.
The study was designed to collect information over 1800 patients with a clinical diagnosis of subacute or chronic eczema, these patients' prescriptions contain Hirudoid® (Hirudoid® alone or in combination with glucocorticoids). Basic demographic information (age, sex, height, weight, lifestyle, occupation), vital signs (blood pressure, heart rate, temperature, etc.), past medical and treatment history, eczema area and severity index (EASI) scores and corresponding symptom scores, Dermatology Life Quality Index (DLQI) score, Investigator's global assessment (IGA) of disease severity score, Visual analogue scale (VAS) with subject's pruritus, photographs of the eczema area and recurrence rate were collected. Data were evaluated for a maximum of 12 weeks according to the clinician's consultation and follow-up (Time points were set at baseline, 1, 2, 3, 4, 8 and 12 weekends). The above data were analysed to explore the optimal treatment modality, dose and treatment period for patients with subacute or chronic eczema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mucopolysaccharide Polysulfate Cream | Prescribed only for patients with Mucopolysaccharide Polysulfate Cream. |
| |
| Mucopolysaccharide Polysulfate Cream and glucocorticoids | Patients whose prescriptions contain Mucopolysaccharide Polysulfate Cream and glucocorticoids (Combination therapy, but not always). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mucopolysaccharide Polysulfate Cream | Drug | Patients using Hirudoid® alone |
|
| Measure | Description | Time Frame |
|---|---|---|
| EASI score | The greatest change in EASI score occurred during the 12 weeks (follow up point were set at baseline, 1, 2, 3, 4, 8 and 12 weekends) after dosing compared to baseline. | It could be any time point in the weekend of 1, 2, 3, 4, 8 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical manifestations. Including Erythema, Thickness (induration, papulation, swelling), Scratching (excoriation), Lichenification (lined skin, furrowing, prurigo nodules). | The change in clinical manifestations during treatment compared with at baseline: including Erythema, Thickness (induration, papulation, swelling), Scratching (excoriation), Lichenification (lined skin, furrowing, prurigo nodules). Score 0 = no skin lesions, Score 1 = mild, requiring close observation to be seen, Score 2 = moderate, signs visible, Score 3 = severe, signs very visible. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with subacute or chronic eczema
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lingfeng Li | Contact | 010-63138585 | zoonli@sina.com | |
| Yue Li | Contact | 13661202501 | 13661202501@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lingfeng Li | Beijing Friendship Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100050 | China |
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| OTHER |
| Beijing Boai Hospital | OTHER |
| Guangxi Ruikang Hospital | OTHER |
| The Third Affiliated Hospital of Southern Medical University | OTHER_GOV |
| The Second Affiliated Hospital of Jiaxing University | OTHER |
| Wuxi People's Hospital | OTHER |
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| Mucopolysaccharide Polysulfate Cream and glucocorticoids | Drug | Patients using Hirudoid® and glucocorticoids (Combination therapy, but not always) |
|
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| Baseline, 1, 2, 3, 4, 8 and 12 weekends |
| Visual analogue scale (VAS) score | The degree of improvement in the subject's self-assessment of visual analogue scale (VAS) compared with that at baseline. The Visual analogue scale (VAS) score was included 11 levels, the minimum value is zero, which means no pruritus; the maximum value is 10, which means extreme pruritus. | Baseline, 1, 2, 3, 4, 8 and 12 weekends |
| The investigator's global assessment (IGA) score | The investigator's global assessment (IGA) of disease severity compared to that at baseline. The investigator's global assessment (IGA) score was included 5 levels, the minimum value is zero, which means no eczema-like lesions; the maximum value is 4, which means extremely severe eczema-like lesions. | Baseline, 1, 2, 3, 4, 8 and 12 weekends |
| Recurrence rate. | (Recurrence follow-up on the 8th and 12th weekends is only for patients who have recovered within 4 weeks. Recurrence rate = number of recurrences / number of recovered persons * 100%); Definition of recovery: Subjects with an IGA score of 0 or 1 during the treatment period (within the first 4 weeks). Definition of relapse: A recovered patient with an IGA score ≥ 2 at follow-up was judged to be recurred. | 8 and 12 weekends |
| Dermatology Life Quality Index (DLQI) score. | The Dermatology Life Quality Index (DLQI) score was included 10 questions, each question contains 4 levels, serious (3 score), moderate (2 score), mild (1 score), none or uncorrelated (0 score), respectively. Higher scores indicate greater troubles and annoyances on dermatology life quality from eczema. | Baseline, 1, 2, 3, 4, 8 and 12 weekends |
| Adverse event | Adverse event/serious adverse event was evaluated. | 1, 2, 3, 4, 8 and 12 weekends |
| ID | Term |
|---|---|
| D004485 | Eczema |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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| ID | Term |
|---|---|
| C046596 | Hirudoid |
| D005938 | Glucocorticoids |
| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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