Phase III Clinical Study of VC005 in Adult and Adolescents With Mild to Moderate Atopic Dermatitis

Jiangsu Vcare PharmaTech

Status and phase: Enrolling; Phase 3

Conditions: Atopic Dermatitis

Treatments: Drug: VC005 Placebo; Drug: VC005

Study type: Interventional

Funder types: Industry

Identifiers

NCT07592585

VC005-303

Details and patient eligibility

About

A multicenter, randomized, double-blind, vehicle controlled phase III clinical study to evaluate the efficacy and safety of VC005 in adults and adolescents with mild to moderate atopic dermatitis

Enrollment: 360 estimated patients

Sex: All

Ages: 12+ 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 12 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. Patients whose AD course is judged by the investigator as unstable(spontaneous improvement or rapid worsening) within 2 weeks prior to baseline;
2. At screening and baseline, lesions are localized only to the hands or feet, with no prior history of involvement of other typical areas (such as the face or flexural areas);
3. Skin damage or abnormalities that may affect the evaluation of the investigational drug administration site (e.g., pigmentation, extensive scarring, tattoos, etc., at the affected area);
4. At screening and baseline, presence of skin diseases that may affect the evaluation of the administration site, including but not limited to: psoriasis, acne, skin cancer, generalized erythroderma, Netherton syndrome, etc.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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360 participants in 2 patient groups, including a placebo group

VC005 groups

Experimental group

Treatment:

Drug: VC005

VC005 Placebo group

Placebo Comparator group

Treatment:

Drug: VC005 Placebo