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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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13 October 2020 |
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Main ID: |
ChiCTR2000037278 |
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Date of registration:
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2020-08-27 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effects and Safety of Simvastatin Ointment in the Treatment of Congenital Ichthyosis
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Scientific title:
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Effects and Safety of Simvastatin Ointment in the Treatment of Congenital Ichthyosis |
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Date of first enrolment:
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2020-09-01 |
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Target sample size:
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ARCI group:45;XLI group:10; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=58700 |
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Study type:
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Interventional study |
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Study design:
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Parallel
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Phase:
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0
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Countries of recruitment
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China
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Contacts
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Name:
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Xia Yu
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Address:
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1665 Kongjiang Road, Yangpu District, Shanghai, China
200092
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Telephone:
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+86 13916868343 |
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Email:
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yuxia@xinhuamed.com.cn |
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Affiliation:
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Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine |
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Name:
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Zhirong Yao
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Address:
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1665 Kongjiang Road, Yangpu District, Shanghai, China
200092
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Telephone:
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+86 13651652986 |
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Email:
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yaozhirong@xinhuamed.com.cn |
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Affiliation:
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Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. The subject is clinically, pathologically and genetically diagnosed as juvenile congenital ichthyosis (autosomal recessive or X-linked).
2. The subject is of stable vital signs.
3. The subject or guardian agrees to participate in the study and signs the informed consent.
4. There is no restriction on age or gender.
Exclusion criteria: 1. Patients who have serious allergy or infection in the skin lesions;
2. Patients who are allergic to the drugs used in this study;
3. Patients who used oral lipid-lowering drugs in recent three months;
4. Patients who had oral retinoids in recent three months;
5. Patients who had oral hormone or other immunosuppressive drugs in recent three months;
6. Patients with precancerous skin damage;
7. Patients with severe heart, liver or renal insufficiency;
8. Patients with chronic infection such as HIV, HBV and HCV;
9. Lactating women, pregnant women or patients with potential pregnancy during treatment and refusing contraception;
10. Those who can't insist on treatment;
11. Patients enrolled in any other clinical trials.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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inherited ichthyosis
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Intervention(s)
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ARCI group:Concentration of simvastatin cream;XLI group:Concentration of simvastatin cream;
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Primary Outcome(s)
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thickness of skin lesion / desquamation degree;discomfort such as pain or itching;Erythema;influence on daily life;histopathology and electron microscope;Immunohistochemistry;mRNA and protein levels of defective genes;
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Secondary Outcome(s)
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compete blood count;urinalysis;serum lipid metabolism;liver function and renal function;myocardial enzymogram;EKG;X-ray;abdominal ultrasound;
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Source(s) of Monetary Support
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Pharmacy of Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
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Ethics review
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Status: Approved
Approval date: 02/01/2020
Contact:
Min Shi
+86 21 25076143
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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