Clinical Study to Evaluate the Safety, Pharmacokinetics and Efficacy of VC005 in Adolescent Subjects With Mild to Moderate Atopic Dermatitis

Jiangsu Vcare PharmaTech

Status and phase

Enrolling

Phase 1

Conditions

Atopic Dermatitis (AD)

Treatments

Drug: VC005

Study type

Interventional

Funder types

Industry

Identifiers

VC005-106

Details and patient eligibility

About

This is a single arm, and open-label phase I study

Enrollment

10 estimated patients

Sex

All

Ages

12 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

When giving informed consent, the age range is 12-18 years old (including 12 years old), with no gender restrictions;
The subjects and their guardians voluntarily sign an informed consent form (dated), indicating that the subjects have been informed of all relevant parts of the study;
All women and all men with the potential to conceive must be willing to use at least one highly effective method of contraception from the time of signing the informed consent form until 3 months after the last administration of the investigational drug

Exclusion criteria

Subjects suspected to be allergic to VC005 gel or to excipients in VC005 gel, or with ≥ 2 kinds of drug allergy history in the past;
The researchers believe that there may be skin injuries or abnormalities in the subjects that could affect the evaluation of the administration site of the investigational drug；
The researchers believe that the subjects have clinically relevant skin diseases that are contraindicated in the study or affect the evaluation of the administration site, including but not limited to psoriasis, acne, dysplastic nevi, and skin cancer;