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

April 9, 2026 updated by: Jiangsu vcare pharmaceutical technology co., LTD
This is a single arm, and open-label phase I study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Hangzhou First People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VC005
Drug: VC005
VC005 with Local topical application

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area Under the Curve From Time Zero to Last Quantifiable Concentration(AUC）
Time Frame: Day1，Day28
Day1，Day28
Peak Plasma Concentration (Cmax）
Time Frame: Day1，Day28
Day1，Day28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu vcare pharmaceutical technology co., LTD

Investigators

  • Principal Investigator: Liming Wu, First People's Hospital of Hangzhou

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2025

Primary Completion (Actual)

February 6, 2026

Study Completion (Actual)

February 28, 2026

Study Registration Dates

First Submitted

December 29, 2025

First Submitted That Met QC Criteria

December 29, 2025

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VC005-106

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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