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

NCT ID: NCT07329101

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-11
• Study Completion Date: 2026-06-30

Brief Summary

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

Conditions

Atopic Dermatitis (AD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VC005

Group Type: EXPERIMENTAL

VC005

Intervention Type: DRUG

VC005 with Local topical application

Interventions

VC005

VC005 with Local topical application

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu vcare pharmaceutical technology co., LTD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liming Wu

Role: PRINCIPAL_INVESTIGATOR

First People's Hospital of Hangzhou

Locations

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

xiaojuan lai

Role: CONTACT

lai_xiaojuan@vcarepharmatech.com

15358160458

Facility Contacts

Liming Wu

Role: primary

Other Identifiers

VC005-106

Identifier Type: -

Identifier Source: org_study_id