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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorJiangsu vcare pharmaceutical technology co., LTD

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

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 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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • VC005

    Drug

    VC005 Placebo group with Local topical application

  • VC005 Placebo

    Drug

    VC005 Placebo group with Local topical application

Treatment groups

360 Participants
are divided into 2 treatment groups
Group A: VC005 groupsExperimental treatment 1 intervention
Group B: VC005 Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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