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

Eczema Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05439577
• Other study ID #: CMS-Hirudoid-001
• Status: Recruiting
• Start date: September 23, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: June 2022
• Source: Shenzhen Kangzhe Pharmaceutical Co., Ltd.
• Contact: Lingfeng Li
• Phone: 010-63138585
• Email: zoonli[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: November 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eczema

Intervention

Drug:
• Mucopolysaccharide Polysulfate Cream
Patients using Hirudoid® alone
• Mucopolysaccharide Polysulfate Cream and glucocorticoids
Patients using Hirudoid® and glucocorticoids (Combination therapy, but not always)

Locations

Country	Name	City	State
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing

Sponsors (10)

Lead Sponsor	Collaborator
Shenzhen Kangzhe Pharmaceutical Co., Ltd.	Beijing Boai Hospital, Beijing Friendship Hospital, Guangxi Ruikang Hospital, LanZhou University, The First Hospital of Hebei Medical University, The Second Affiliated Hospital of Jiaxing University, The Third Affiliated Hospital of Southern Medical University, Wuxi People's Hospital, Xingtai People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Adverse event	Adverse event/serious adverse event was evaluated.	1, 2, 3, 4, 8 and 12 weekends