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

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.

Study Overview

• Status: Recruiting
• Conditions: Eczema
• Intervention / Treatment: Drug: Mucopolysaccharide Polysulfate Cream; Drug: Mucopolysaccharide Polysulfate Cream and glucocorticoids

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.

• Study Type: Observational
• Enrollment (Anticipated): 1800

Contacts and Locations

• Study Contact: Name: Lingfeng Li; Phone Number: 010-63138585; Email: zoonli@sina.com
• Study Contact Backup: Name: Yue Li; Phone Number: 13661202501; Email: 13661202501@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Recruiting
      • Beijing Friendship Hospital, Capital Medical University
      • Contact: Lingfeng Li; Phone Number: 010-63138585; Email: zoonli@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with subacute or chronic eczema

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mucopolysaccharide Polysulfate Cream; Prescribed only for patients with Mucopolysaccharide Polysulfate Cream.	Drug: Mucopolysaccharide Polysulfate Cream; Patients using Hirudoid® alone; Other Names: Hirudoid®
Mucopolysaccharide Polysulfate Cream and glucocorticoids; Patients whose prescriptions contain Mucopolysaccharide Polysulfate Cream and glucocorticoids (Combination therapy, but not always).	Drug: Mucopolysaccharide Polysulfate Cream and glucocorticoids; Patients using Hirudoid® and glucocorticoids (Combination therapy, but not always); Other Names: Hirudoid® and glucocorticoids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Shenzhen Kangzhe Pharmaceutical Co., Ltd.
• Collaborators: LanZhou University; Beijing Friendship Hospital; The Third Affiliated Hospital of Southern Medical University; The First Hospital of Hebei Medical University; Xingtai People's Hospital; Beijing Boai Hospital; Wuxi People's Hospital; The Second Affiliated Hospital of Jiaxing University; Guangxi Ruikang Hospital
• Investigators: Principal Investigator: Lingfeng Li, Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2021
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): November 30, 2022

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: June 26, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 26, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Eczema; Physiological Effects of Drugs; Anti-Inflammatory Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anticoagulants; Glucocorticoids; Heparinoids
• Other Study ID Numbers: CMS-Hirudoid-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No