ITMCTR2000003604
Not yet recruiting
Phase 1
Safety, preliminary efficacy and immunogenicity of traditional Chinese medicine miRNA hydrogel in the treatment of eczema: a randomized, double-blind, placebo-controlled, dose-increasing clinical study
Shanghai Skin Disease Hospital0 sitesTBD
Conditionseczema
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- eczema
- Sponsor
- Shanghai Skin Disease Hospital
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Those who voluntarily sign the informed consent form.
- •2\. Aged 18 to 65 years old;
- •3\. The clinical diagnosis of patients with subacute eczema is mainly based on clinical diagnosis, refer to the guidelines for diagnosis and treatment of eczema of Immunology Group of Dermatology and venereology Branch of Chinese Medical Association (2011\), Chinese Clinical Dermatology (2009\), eczema (eczema) TCM expert consensus (2016\);
- •4\. The involved area of the skin lesion is less than 10% of the body surface area ((BSA)) (according to the palm method, the palm area of the patient is set at 1%);
- •5\. The degree of skin lesion was moderate or more, according to the researchers' overall evaluation (IGA) score standard, that is, IGA \>\=3;
- •6\. The total score of skin lesion symptom (TSS) 10\-18\.
Exclusion Criteria
- •1\. Patients with any systemic disease or other active skin diseases that may affect the evaluation of the test results (such as acute generalized eczema, psoriasis), or patients with scars, birthmarks, tattoos, sunburn, etc., that may affect the evaluation of skin lesions;
- •2\. Patients whose skin lesions involve facial or skin folds, or whose lesions are limited to the palms and soles of the feet;
- •3\. Patients with bacterial, viral and fungal infections at the medication site need to be treated with anti\-infection therapy;
- •4\. In the last month or now suffer from viral infectious skin diseases, such as herpes simplex, chicken pox and other patients;
- •5\. The following treatments were used within a limited time before administration:
- •Use topical drugs in the affected areas, including emollients for 3 days;
- •Systematic application of antihistamines for 7 days;
- •Systematic application of glucocorticoid for 4 weeks;
- •Immunosuppressant for 4 weeks;
- •UV treatment for 4 weeks;
Outcomes
Primary Outcomes
Not specified
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