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

NCT06891040 | Completed Phase 2

• 1 other identifier: VC005-203
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Changes in EASI（Eczema area and severity index） from baseline

  8 week

Study Arms (3)

VC005 Low Dose groups

EXPERIMENTAL

VC005 group with Local topical application

Drug: VC005 groups

VC005 high Dose groups

EXPERIMENTAL

VC005 group with Local topical application

Drug: VC005 groups

VC005 Placebo groups

PLACEBO COMPARATOR

VC005 Placebo group with Local topical application

Drug: VC005 Placebo group

Interventions

VC005 groups DRUG

VC005 group with Local topical application

VC005 Low Dose groups; VC005 high Dose groups

VC005 Placebo group DRUG

VC005 Placebo group with Local topical application

VC005 Placebo groups

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);
• The age requirement for signing the ICF is 18 years old or above, with no gender restrictions;
• During screening, the diagnosis of atopic dermatitis should be met according to the Hanifin-Rajka criteria;

You may not qualify if:

• Skin damage or abnormalities that may affect the evaluation of the administration site of the investigational drug;
• 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;
• 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;
• Current history of or presence of lymphoproliferative disorders, or signs or symptoms suggesting possible lymphoproliferative disorders, including lymphadenopathy or splenomegaly;
• 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);

Sponsors & Collaborators

• Jiangsu vcare pharmaceutical technology co., LTD: lead

Study Sites (1)

Chinese Academy of Medical Sciences Hospital of Skin Disease

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Qian jin Lu

  Chinese Academy of Medical Sciences Hospital of Skin Disease

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 24, 2025
• Study Start: April 28, 2025
• Primary Completion: October 31, 2025
• Study Completion: November 4, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

CN (1)