A Multicenter, Randomized, Double-blind, Vehicle Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of VC005 Gel in Adult Subjects With Mild to Moderate Atopic Dermatitis

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJiangsu vcare pharmaceutical technology co., LTD

About this trial

This is a multicenter, randomized, double-blind, vehicle controlled phase II clinical study to evaluate the efficacy and safety of VC005 gel in adult subjects with mild to moderate atopic dermatitis

Eligibility criteria

Qualifiers

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 18 years old or above, with no gender restrictions;

During screening, the diagnosis of atopic dermatitis should be met according to the Hanifin-Rajka criteria.

Disqualifiers

Patients judged by the investigator to have an unstable course of Atopic Dermatitis (AD) (spontaneous improvement or rapid deterioration) within 2 weeks before baseline;

Patients with skin lesions limited to the hands or feet at screening and baseline, with no prior history of involvement in other typical areas (such as the face or flexural folds);

Skin damage or abnormalities that may affect the evaluation of the investigational drug administration site (e.g., hyperpigmentation, large-area scars, tattoos, etc. at the affected site);

Presence of skin diseases at screening and baseline that may affect the evaluation of the administration site, including but not limited to: psoriasis, acne, skin cancer, generalized erythroderma, Netherton's syndrome, etc.;

Trial design

Treatments tested in this trial

  • VC005 group
  • VC005 Placebo group

Treatment groups

120 Participants
are divided into 4 treatment groups