psoriasis
Conditions
Interventions
Experimental group:Apply this Imiquimod cream to the base of the nail on the left hand after using a microneedle, once in the morning and once in the evening
Control group:Apply this imiquimod cream to the base of the nail on the right hand, once in the morning and once in the evening.
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 65 years (including boundary values), patients with psoriatic nail changes affecting both hands, male or female; 2. Diagnosed with psoriatic nails by two associate senior dermatologists in the outpatient clinic based on clinical examination or histopathology, with disease stability confirmed by the investigator for at least 6 months prior to screening; 3. Understanding of the trial process and voluntary signing of the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Current clinical diagnosis of unstable plaque psoriasis or other types of psoriasis, or psoriasis requiring active treatment during the trial period; 2. Presence of other inflammatory skin conditions (e.g., atopic dermatitis, contact dermatitis) or infectious skin conditions (bacterial, fungal, viral infections) in the treatment area that may affect disease assessment; 3. Presence of symptoms or signs in the treatment area that may affect efficacy or safety assessment, such as hyperpigmentation, extensive scarring, skin lesions with color changes, or sunburn; 4. Presence of severe organ or systemic diseases, including cardiovascular (e.g., heart failure, unstable angina), hepatic (e.g., cirrhosis), renal (e.g., renal failure), pulmonary (e.g., chronic obstructive pulmonary disease), endocrine (e.g., Cushing's syndrome, Addison's disease), neurological, and hematological disorders, as well as other autoimmune diseases, malignancies, or other conditions deemed unsuitable for study participation by the investigator; 5 Patients with known hypersensitivity to Venmod Cream or any other component of the topical cream; 6 Chronic or acute infections requiring systemic antibiotic, antiviral, antiparasitic, antiprotozoal, or antifungal therapy within 4 weeks prior to study initiation; 7. Use of topical psoriasis treatments (corticosteroids, retinoids, vitamin D derivatives, pimecrolimus, tacrolimus, PDE4 inhibitors, salicylic acid, anthralin, coal tar, etc.) within 2 weeks prior to study initiation; 8. Received phototherapy (PUVA, UVB, etc.) or conventional systemic psoriasis medications (glucocorticoids, retinoids, methotrexate, tacrolimus, cyclosporine, PDE4 inhibitors, JAK inhibitors, traditional Chinese medicine, etc.) within 1 month prior to study initiation; 9. Chemotherapy or radiotherapy within 3 months prior to study initiation; 10. Biologic therapy within 3 months prior to study initiation; 11. Current use or initiation during the study of medications that may affect psoriasis (antimalarials, lithium, interferons, imiquimod, etc.); 12. Physical examination or laboratory findings judged by the investigator to be clinically significant abnormalities (white blood cell count 15×10?/L; hemoglobin 2 times the upper limit of normal; creatinine > 1.5 times the upper limit of normal; triglycerides > 3 times the upper limit of normal; total cholesterol > 2 times the upper limit of normal); 13 Pregnant (positive pregnancy test), lactating, or women attempting to conceive; 14 Women of childbearing potential who had unprotected intercourse with a male partner within 2 weeks prior to screening, or who refuse to use appropriate contraception during the trial, or who refuse to use reliable contraception during the trial and for one month after the last use of study drug; 15 Individuals with planned hospitalization/surgery during the trial period; 16. Participation in another clinical study within 1 month prior to enrollment in this study; 17. Conditions likely to affect subject compliance, such as frequent business travel or extended vacations, substance abuse, drug dependency, or psychiatric disorders; 18. Other conditions deemed inappropriate for inclusion in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nail Psoriasis Severity Index(NAPSI);modified Nail Psoriasis Severity Index(mNAPSI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Dermatology Life Quality Index(DLQI); Visual Analogue Scale(VAS);Photograph of the nail bed of the affected nail;Dermoscopy;Ultrasound examination; | — |
Countries
China
Contacts
Public ContactCui Yong
China-Japan Friendship Hospital
Outcome results
None listed