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A Multicentre Study to Explore the Efficacy and Safety of Mucopolysaccharide Polysulfate Cream in Patients With Eczema

NCT ID: NCT05439577

Last Updated: 2022-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-23

Study Completion Date

2022-11-30

Brief Summary

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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.

Detailed Description

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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® (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.

Conditions

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Eczema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mucopolysaccharide Polysulfate Cream

Prescribed only for patients with Mucopolysaccharide Polysulfate Cream.

Mucopolysaccharide Polysulfate Cream

Intervention Type DRUG

Patients using Hirudoid® alone

Mucopolysaccharide Polysulfate Cream and glucocorticoids

Patients whose prescriptions contain Mucopolysaccharide Polysulfate Cream and glucocorticoids (Combination therapy, but not always).

Mucopolysaccharide Polysulfate Cream and glucocorticoids

Intervention Type DRUG

Patients using Hirudoid® and glucocorticoids (Combination therapy, but not always)

Interventions

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Mucopolysaccharide Polysulfate Cream

Patients using Hirudoid® alone

Intervention Type DRUG

Mucopolysaccharide Polysulfate Cream and glucocorticoids

Patients using Hirudoid® and glucocorticoids (Combination therapy, but not always)

Intervention Type DRUG

Other Intervention Names

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Hirudoid® Hirudoid® and glucocorticoids

Eligibility Criteria

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Inclusion Criteria

1. 18-75 years of age, male or female;.
2. Patients with a clinical diagnosis of subacute or chronic eczema and whose prescription contains Hirudoid®.
3. Subjects fully understand the content of this study, sign informed consent.

Exclusion Criteria

1. Hypersensitivity to any of the ingredients of this product.
2. Patients with heparin hypersensitivity, bleeding-prone constitution and known heparin-induced thrombocytopenia.
3. Open wounds and broken skin and mucous membranes
4. Patients with localized combined bacterial, viral and fungal infections.
5. Pregnant or lactating women or those who are unable to use contraception during the study period
6. Those with psychiatric disorders, poor compliance and unable to complete the study.
7. Any other reason that the investigator considers inappropriate for inclusion.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Friendship Hospital

OTHER

Sponsor Role collaborator

LanZhou University

OTHER

Sponsor Role collaborator

The First Hospital of Hebei Medical University

OTHER

Sponsor Role collaborator

Xingtai People's Hospital

OTHER

Sponsor Role collaborator

Beijing Boai Hospital

OTHER

Sponsor Role collaborator

Guangxi Ruikang Hospital

OTHER

Sponsor Role collaborator

The Third Affiliated Hospital of Southern Medical University

OTHER_GOV

Sponsor Role collaborator

The Second Affiliated Hospital of Jiaxing University

OTHER

Sponsor Role collaborator

Wuxi People's Hospital

OTHER

Sponsor Role collaborator

Shenzhen Kangzhe Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lingfeng Li

Role: PRINCIPAL_INVESTIGATOR

Beijing Friendship Hospital

Locations

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Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lingfeng Li

Role: CONTACT

Phone: 010-63138585

Email: [email protected]

Yue Li

Role: CONTACT

Phone: 13661202501

Email: [email protected]

Facility Contacts

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Lingfeng Li

Role: primary

Other Identifiers

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CMS-Hirudoid-001

Identifier Type: -

Identifier Source: org_study_id