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

S

Shenzhen Kangzhe Pharmaceutical Co., Ltd.

Status

Enrolling

Conditions

Eczema

Treatments

Drug: Mucopolysaccharide Polysulfate Cream
Drug: Mucopolysaccharide Polysulfate Cream and glucocorticoids

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT05439577
CMS-Hirudoid-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment

1,800 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

1,800 participants in 2 patient groups

Mucopolysaccharide Polysulfate Cream
Description:
Prescribed only for patients with Mucopolysaccharide Polysulfate Cream.
Treatment:
Drug: Mucopolysaccharide Polysulfate Cream
Mucopolysaccharide Polysulfate Cream and glucocorticoids
Description:
Patients whose prescriptions contain Mucopolysaccharide Polysulfate Cream and glucocorticoids (Combination therapy, but not always).
Treatment:
Drug: Mucopolysaccharide Polysulfate Cream and glucocorticoids

Trial contacts and locations

1

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Central trial contact

Lingfeng Li; Yue Li

Data sourced from clinicaltrials.gov

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