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

Phase 1

• Conditions: eczema

• Registration Number: ITMCTR2000003604
• Lead Sponsor: Shanghai Skin Disease Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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;
6. Patients who are expected to be exposed to intense UV conditions (such as sunbathing or UV therapy, etc., excluding daily sun exposure) or using suntanning agents during the trial;
7. Laboratory tests during medical history, physical examination and screening indicate that there are currently patients with significant heart, lung, gastrointestinal, liver, kidney, blood, neurological and mental disorders;
8. In the patients with abnormal hepatorenal function, the ALT or AST of liver function damage was more than 1.5 times of the normal upper limit, and the renal function BUN and Cr were higher than the normal upper limit and had clinical significance;
9. Patients who have a history of allergy to any component of the experimental drug;
10. Patients with a history of severe hypersensitivity (sudden, life-threatening systemic anaphylaxis) to food, drugs, insect venom, or rubber;
11. Patients who participated in clinical studies of other experimental drugs within one month;
12. Alcoholism (drinking more than 14 units per week (male) and 7 units (female), 1 unit = 360mL beer; 150mL wine; 45mL liquor) and history of drug use are known to be drug dependent patients;
13. Women of childbearing age who are pregnant, breastfeeding or planning pregnancy, or who are unable to use effective contraceptive measures (condoms, oral contraceptive, IUD, abstinence, etc.) during the trial;
14. Other researchers believe that it is not suitable for patients to participate in the trial.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total symptom score (TSS);