Phase II Clinical Study to Evaluate the Efficacy and Safety of VC005 in Adult Subjects With Mild to Moderate Atopic Dermatitis

Phase 2

Recruiting

• Conditions: Atopic Dermatitis
• Interventions: Drug: VC005 groups; Drug: VC005 Placebo group

• Registration Number: NCT06891040
• Lead Sponsor: Jiangsu vcare pharmaceutical technology co., LTD

Brief Summary

A multicenter, randomized, double-blind, vehicle controlled phase II clinical study

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-18
• Study First Submitted QC: 2025-03-18
• Study First Posted: 2025-03-24
• Study Start: 2025-04-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-08
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

1. Subjects fully understand this study, are able to follow the relevant procedures of the trial, voluntarily participate in the clinical trial, and sign the informed consent form (ICF);
2. The age requirement for signing the ICF is 18 years old or above, with no gender restrictions;
3. During screening, the diagnosis of atopic dermatitis should be met according to the Hanifin-Rajka criteria;

Exclusion Criteria

1. Skin damage or abnormalities that may affect the evaluation of the administration site of the investigational drug;
2. Skin diseases that are contraindicated in research or affect the evaluation of drug administration sites, including but not limited to psoriasis, acne, and skin cancer;
3. Suffering from autoimmune diseases other than AD, such as inflammatory bowel disease and rheumatoid arthritis, and the researchers believe that this disease will be detrimental to the evaluation of this study;
4. Current history of or presence of lymphoproliferative disorders, or signs or symptoms suggesting possible lymphoproliferative disorders, including lymphadenopathy or splenomegaly;
5. Various malignant tumors, or any history of malignant tumors within the past 5 years prior to screening (excluding completely resected cervical carcinoma in situ, non metastatic squamous cell carcinoma, basal cell carcinoma, or papillary thyroid carcinoma);

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VC005 Low Dose groups	VC005 groups	VC005 group with Local topical application
VC005 high Dose groups	VC005 groups	VC005 group with Local topical application
VC005 Placebo groups	VC005 Placebo group	VC005 Placebo group with Local topical application

Primary Outcome Measures

Name	Time	Method
Changes in EASI（Eczema area and severity index） from baseline	8 week

Trial Locations

Locations (1)

Chinese Academy of Medical Sciences Hospital of Skin Disease; 🇨🇳 Nanjing, Jiangsu, China