Evaluating VC005 for treating mild to moderate atopic dermatitis in adults
A Multicenter, Randomized, Double-blind, Vehicle Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of VC005 in Adult Subjects With Mild to Moderate Atopic Dermatitis
This study is testing a new treatment called VC005 to see if it can help adults with mild to moderate eczema feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 114 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jiangsu vcare pharmaceutical technology co., LTD Industry-sponsored |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06891040 on ClinicalTrials.gov |
What this trial studies
This phase II clinical study aims to assess the efficacy and safety of VC005 in adult subjects diagnosed with mild to moderate atopic dermatitis. The study is designed as a multicenter, randomized, double-blind, vehicle-controlled trial, which means participants will be randomly assigned to receive either the VC005 treatment or a placebo. The trial will follow strict protocols to ensure reliable results and participant safety throughout the evaluation period.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with mild to moderate atopic dermatitis.
Not a fit: Patients with other skin diseases or autoimmune conditions that could interfere with the evaluation of the treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from mild to moderate atopic dermatitis.
How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in treating atopic dermatitis with novel therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
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);
Where this trial is running
Nanjing, Jiangsu
- Chinese Academy of Medical Sciences Hospital of Skin Disease — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Qian jin Lu — Chinese Academy of Medical Sciences Hospital of Skin Disease
- Study coordinator: Xiaojuan Lai
- Email: lai_xiaojuan@vcarepharmatech.com
- Phone: 15358160458
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.