EczemaNCT05439577
A Multicentre Study to Explore the Efficacy and Safety of Mucopolysaccharide Polysulfate Cream in Patients With Eczema
An observational study of Eczema, run by Shenzhen Kangzhe Pharmaceutical Co., Ltd. at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Eczema
- What is being tested?
- Mucopolysaccharide Polysulfate Cream and Mucopolysaccharide Polysulfate Cream and glucocorticoids
- How many people
- 1,800 participants
- Where
- 1 siteChina
- Study dates
- 23 Sep 2021to 30 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with subacute or chronic eczema
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Lingfeng Li, 010-63138585, zoonli@sina.com
About this study
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
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.
Read the 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.
- Conditions
- Eczema
- Being tested
- Mucopolysaccharide Polysulfate Cream, Mucopolysaccharide Polysulfate Cream and glucocorticoids
- Medical subject headings
- Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mucopolysaccharide Polysulfate CreamDrug
Also called Hirudoid®
Patients using Hirudoid® alone
Mucopolysaccharide Polysulfate Cream and glucocorticoidsDrug
Also called Hirudoid® and glucocorticoids
Patients using Hirudoid® and glucocorticoids (Combination therapy, but not always)
| Study group | Role | What they receive |
|---|---|---|
| Mucopolysaccharide Polysulfate Cream | Prescribed only for patients with Mucopolysaccharide Polysulfate Cream. Receives: Drug: Mucopolysaccharide Polysulfate Cream | |
| Mucopolysaccharide Polysulfate Cream and glucocorticoids | Patients whose prescriptions contain Mucopolysaccharide Polysulfate Cream and glucocorticoids (Combination therapy, but not always). Receives: Drug: Mucopolysaccharide Polysulfate Cream and glucocorticoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 1, 2, 3, 4, 8 and 12 weekends
Adverse event
Adverse event/serious adverse event was evaluated.
Measured: 1, 2, 3, 4, 8 and 12 weekends
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start23 Sep 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EczemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Kangzhe Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Friendship Hospital, LanZhou University, The First Hospital of Hebei Medical University, Xingtai People's Hospital, Beijing Boai Hospital, Guangxi Ruikang Hospital, The Third Affiliated Hospital of Southern Medical University, The Second Affiliated Hospital of Jiaxing University, Wuxi People's Hospital
- Responsible party
- Sponsor
- Investigators
- Lingfeng Li, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439577
- Sponsor's protocol ID
- CMS-Hirudoid-001
- Status last verified
- Jun 2022
- First submitted
- 21 Jun 2022
- Last updated
- 30 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05439577
- Acronym / sponsor ID
- CMS-Hirudoid-001
- Conditions
- Eczema
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Shenzhen Kangzhe Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Beijing Friendship Hospital, LanZhou University, The First Hospital of Hebei Medical University, Xingtai People's Hospital, Beijing Boai Hospital, Guangxi Ruikang Hospital, The Third Affiliated Hospital of Southern Medical University, The Second Affiliated Hospital of Jiaxing University, Wuxi People's Hospital
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mucopolysaccharide Polysulfate Cream | – | Drug: Mucopolysaccharide Polysulfate CreamPrescribed only for patients with Mucopolysaccharide Polysulfate Cream. |
| Mucopolysaccharide Polysulfate Cream and glucocorticoids | – | Drug: Mucopolysaccharide Polysulfate Cream and glucocorticoidsPatients whose prescriptions contain Mucopolysaccharide Polysulfate Cream and glucocorticoids (Combination therapy, but not always). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with subacute or chronic eczema
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mucopolysaccharide Polysulfate CreamAlso: Hirudoid®Patients using Hirudoid® alone | Drug | Mucopolysaccharide Polysulfate Cream |
| Mucopolysaccharide Polysulfate Cream and glucocorticoidsAlso: Hirudoid® and glucocorticoidsPatients using Hirudoid® and glucocorticoids (Combination therapy, but not always) | Drug | Mucopolysaccharide Polysulfate Cream and glucocorticoids |
Primary outcome
EASI score
Time frame: It could be any time point in the weekend of 1, 2, 3, 4, 8 and 12
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.
6 secondary outcomes
Clinical manifestations. Including Erythema, Thickness (induration, papulation, swelling), Scratching (excoriation), Lichenification (lined skin, furrowing, prurigo nodules).
Time frame: Baseline, 1, 2, 3, 4, 8 and 12 weekends
Visual analogue scale (VAS) score
Time frame: Baseline, 1, 2, 3, 4, 8 and 12 weekends
The investigator's global assessment (IGA) score
Time frame: Baseline, 1, 2, 3, 4, 8 and 12 weekends
Recurrence rate.
Time frame: 8 and 12 weekends
Dermatology Life Quality Index (DLQI) score.
Time frame: Baseline, 1, 2, 3, 4, 8 and 12 weekends
Adverse event
Time frame: 1, 2, 3, 4, 8 and 12 weekends
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lingfeng Li principal investigator
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eczema, run by Shenzhen Kangzhe Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lingfeng Li (010-63138585, zoonli@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EASI score (time frame: It could be any time point in the weekend of 1, 2, 3, 4, 8 and 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2022.