A Multicentre Study to Explore the Efficacy and Safety of Mucopolysaccharide Polysulfate Cream in Patients With Eczema
A Multicentre, Prospective and Registry Study to Explore the Efficacy and Safety of Mucopolysaccharide Polysulfate Cream in the Treatment of Patients With Eczema
1 other identifier
observational
1,800
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 23, 2021
CompletedFirst Submitted
Initial submission to the registry
June 21, 2022
CompletedFirst Posted
Study publicly available on registry
June 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedJune 30, 2022
June 1, 2022
1 year
June 21, 2022
June 26, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (6)
Clinical manifestations. Including Erythema, Thickness (induration, papulation, swelling), Scratching (excoriation), Lichenification (lined skin, furrowing, prurigo nodules).
Baseline, 1, 2, 3, 4, 8 and 12 weekends
Visual analogue scale (VAS) score
Baseline, 1, 2, 3, 4, 8 and 12 weekends
The investigator's global assessment (IGA) score
Baseline, 1, 2, 3, 4, 8 and 12 weekends
Recurrence rate.
8 and 12 weekends
Dermatology Life Quality Index (DLQI) score.
Baseline, 1, 2, 3, 4, 8 and 12 weekends
- +1 more secondary outcomes
Study Arms (2)
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).
Interventions
Patients using Hirudoid® alone
Patients using Hirudoid® and glucocorticoids (Combination therapy, but not always)
Eligibility Criteria
Patients with subacute or chronic eczema
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shenzhen Kangzhe Pharmaceutical Co., Ltd.lead
- Beijing Friendship Hospitalcollaborator
- LanZhou Universitycollaborator
- The First Hospital of Hebei Medical Universitycollaborator
- Xingtai People's Hospitalcollaborator
- Beijing Boai Hospitalcollaborator
- Guangxi Ruikang Hospitalcollaborator
- The Third Affiliated Hospital of Southern Medical Universitycollaborator
- The Second Affiliated Hospital of Jiaxing Universitycollaborator
- Wuxi People's Hospitalcollaborator
Study Sites (1)
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lingfeng Li
Beijing Friendship Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2022
First Posted
June 30, 2022
Study Start
September 23, 2021
Primary Completion
September 30, 2022
Study Completion
November 30, 2022
Last Updated
June 30, 2022
Record last verified: 2022-06