A Multicenter, Randomized, Double-blind, Vehicle Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of VC005 Gel in Adult Subjects With Mild to Moderate Atopic Dermatitis

NCT07598383 | Not Yet Recruiting Phase 2

• 1 other identifier: VC005-209
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized, double-blind, vehicle controlled phase II clinical study to evaluate the efficacy and safety of VC005 gel in adult subjects with mild to moderate atopic dermatitis

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

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

  Week 4

Study Arms (4)

VC005 Dose A group

EXPERIMENTAL

Drug: VC005 group

VC005 Dose B group

EXPERIMENTAL

Drug: VC005 group

VC005 Dose C group

EXPERIMENTAL

Drug: VC005 group

VC005 Placebo group

PLACEBO COMPARATOR

Drug: VC005 Placebo group

Interventions

VC005 group DRUG

VC005 group with Local topical application

VC005 Dose A group; VC005 Dose B group; VC005 Dose C group

VC005 Placebo group DRUG

VC005 Placebo group with Local topical application

VC005 Placebo group

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:

• Patients judged by the investigator to have an unstable course of Atopic Dermatitis (AD) (spontaneous improvement or rapid deterioration) within 2 weeks before baseline;
• Patients with skin lesions limited to the hands or feet at screening and baseline, with no prior history of involvement in other typical areas (such as the face or flexural folds);
• Skin damage or abnormalities that may affect the evaluation of the investigational drug administration site (e.g., hyperpigmentation, large-area scars, tattoos, etc. at the affected site);
• Presence of skin diseases at screening and baseline that may affect the evaluation of the administration site, including but not limited to: psoriasis, acne, skin cancer, generalized erythroderma, Netherton's syndrome, etc.;
• Patients with a history of malignant tumors, with the exception of: cervical carcinoma in situ, non-metastatic cutaneous squamous cell carcinoma or basal cell carcinoma, or non-metastatic papillary thyroid carcinoma that have been completely resected with no evidence of recurrence for more than 5 years of survival.

Sponsors & Collaborators

• Jiangsu vcare pharmaceutical technology co., LTD: lead

Study Sites (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, 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

• Liming Wu

  First People's Hospital of Hangzhou

  PRINCIPAL INVESTIGATOR

Central Study Contacts

xiaojuan lai

CONTACT

+8615358160458; lai_xiaojuan@vcarepharmatech.com

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: May 14, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): February 22, 2027
• Study Completion (Estimated): February 22, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-04

Locations

CN (1)