Recruiting NCT07592585
Phase III Clinical Study of VC005 in Adult and Adolescents With Mild to Moderate Atopic Dermatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VC005, VC005 Placebo.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis. Basic parameters: from 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Phase III Clinical Study to Evaluate the Efficacy and Safety of VC005 in Adult and Adolescents With Mild to Moderate Atopic Dermatitis
Overview
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
Interventions
- Drug VC005
VC005 Placebo group with Local topical application - Drug VC005 Placebo
VC005 Placebo group with Local topical application
Primary outcome measures
- Proportion of subjects achieving an Investigator's Global Assessment (IGA) response (defined as an IGA score of 0 or 1 with a reduction of ≥2 points from baseline) [Time frame: Week 8]
Eligibility criteria
Inclusion criteria
- 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 12 years old or above, with no gender restrictions;
- During screening, the diagnosis of atopic dermatitis should be met according to the Hanifin-Rajka criteria.
Exclusion criteria
- Patients whose AD course is judged by the investigator as unstable(spontaneous improvement or rapid worsening) within 2 weeks prior to baseline;
- 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);
- 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);
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Chinese Academy of Medical Sciences Hospital for Skin Disease — Nanjing
Identifiers
NCT: NCT07592585 · VC005-303