Clinical trial NCT05439577: A Multicentre Study to Explore the Efficacy and Safety of Mucopolysaccharide Polysulfate Cream in Patients With Eczema
Official title: A Multicentre, Prospective and Registry Study to Explore the Efficacy and Safety of Mucopolysaccharide Polysulfate Cream in the Treatment of Patients With Eczema
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Eczema
Lead sponsor: Shenzhen Kangzhe Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Beijing Friendship Hospital
name: LanZhou University
name: The First Hospital of Hebei Medical University
name: Xingtai People's Hospital
name: Beijing Boai Hospital
name: Guangxi Ruikang Hospital
name: The Third Affiliated Hospital of Southern Medical University
name: The Second Affiliated Hospital of Jiaxing University
name: Wuxi People's Hospital
First posted: 2022-06-30
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with subacute or chronic eczema

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: EASI score
timeFrame: It could be any time point in the weekend of 1, 2, 3, 4, 8 and 12
Secondary outcomes:
measure: Clinical manifestations. Including Erythema, Thickness (induration, papulation, swelling), Scratching (excoriation), Lichenification (lined skin, furrowing, prurigo nodules).
timeFrame: Baseline, 1, 2, 3, 4, 8 and 12 weekends
measure: Visual analogue scale (VAS) score
timeFrame: Baseline, 1, 2, 3, 4, 8 and 12 weekends
measure: The investigator's global assessment (IGA) score
timeFrame: Baseline, 1, 2, 3, 4, 8 and 12 weekends
measure: Recurrence rate.
timeFrame: 8 and 12 weekends
measure: Dermatology Life Quality Index (DLQI) score.
timeFrame: Baseline, 1, 2, 3, 4, 8 and 12 weekends
measure: Adverse event
timeFrame: 1, 2, 3, 4, 8 and 12 weekends
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Lingfeng Li
role: PRINCIPAL_INVESTIGATOR
References: