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

Jiangsu Vcare PharmaTech

Status and phase: Enrolling; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: VC005 groups; Drug: VC005 Placebo group

Study type: Interventional

Funder types: Industry

Identifiers

NCT06891040

VC005-203

Details and patient eligibility

About

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

Enrollment: 114 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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);

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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114 participants in 3 patient groups, including a placebo group

VC005 Low Dose groups

Experimental group

Description:

VC005 group with Local topical application

Treatment:

Drug: VC005 groups

VC005 high Dose groups

Experimental group

Description:

VC005 group with Local topical application

Treatment:

Drug: VC005 groups

VC005 Placebo groups

Placebo Comparator group

Description:

VC005 Placebo group with Local topical application

Treatment:

Drug: VC005 Placebo group