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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-28

Study Completion Date

2025-12-30

Brief Summary

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

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Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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VC005 Low Dose groups

VC005 group with Local topical application

Group Type EXPERIMENTAL

VC005 groups

Intervention Type DRUG

VC005 group with Local topical application

VC005 high Dose groups

VC005 group with Local topical application

Group Type EXPERIMENTAL

VC005 groups

Intervention Type DRUG

VC005 group with Local topical application

VC005 Placebo groups

VC005 Placebo group with Local topical application

Group Type PLACEBO_COMPARATOR

VC005 Placebo group

Intervention Type DRUG

VC005 Placebo group with Local topical application

Interventions

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VC005 Placebo group

VC005 Placebo group with Local topical application

Intervention Type DRUG

VC005 groups

VC005 group with Local topical application

Intervention Type DRUG

Eligibility Criteria

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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);

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No