MedPath

Clinical study of topical application of Ku-Gan cream in the treatment of mild to moderate atopic dermatitis

Early Phase 1
Recruiting
Conditions
Atopic Dermatitis
Registration Number
ITMCTR2024000196
Lead Sponsor
Shanghai Skin Disease Hospital, Institute of Dermatology, School of Medicine, Tongji University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1.It meets the above diagnostic criteria for atopic dermatitis;
2.Age =18 years and =65 years, gender is not limited;
3.Investigator's global assessment (IGA) score of 2~3 or Eczema area and severity index (EASI) score of 1~21, diagnosed as mild to moderate AD patients;
4.Those who understood, agreed to participate in this study and signed the informed consent form.

Exclusion Criteria

1. Other active skin diseases that may interfere with the assessment of the condition;
2. Patients have been systematically treated with investigational drugs, biologics and immunosuppressive agents within 1 month;
3. In a period of severe uncontrollable acute or chronic local or systemic infection;
4. Patients with severe systemic diseases; or patients whose clinical test indicators fall into one of the following categories: increased alanine aminotransferase or glutamine aminotransferase > 1.5 times the upper limit of normal; increased creatinine > 1.5 times the upper limit of normal; any of the major indicators of routine blood tests (white blood cell count, red blood cell count, haemoglobin volume, platelet count) is below the lower limit of normal; or other laboratory test abnormalities of the investigator Patients judged to be unsuitable for participation in this trial;
5. Patients with a history of malignancy and patients with primary or secondary immunodeficiency and hypersensitivity, or those with a family history of tumours;
6. Who have undergone major surgery within 8 weeks or will require such surgery during the study;
7. Women who are pregnant or breastfeeding;
8. Persons with a history of alcohol, drug or substance abuse;
9. Persons with a history or family history of severe mental illness;
10. Persons who, in the opinion of the investigator, are not suitable for participation in this study for other reasons.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath