Nagashima-type Palmoplantar Keratosis in Adults
Conditions
Interventions
Benvitimod Cream group vs. Placebo group:The patient applied Benvemod cream topically to one side of their hands and feet twice daily. The other side of their hands and feet received a placebo cream t
Sponsors
Dongguan People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older, with no restriction on gender; 2. Patients with Nagashima-type palmoplantar keratoderma (NPPK) confirmed by genetic testing (mutations in SERPINB7 and/or SERPINA12 genes); 3. Clinical manifestations consistent with the characteristics of Nagashima-type palmoplantar keratoderma, with bilateral involvement of both hands and feet: well-demarcated diffuse erythema and non-mutilating hyperkeratosis on the palms and soles, with skin lesions that may extend beyond the palmoplantar boundaries to the dorsal aspects of the hands and feet, the medial aspects of the wrists, the ankles, and the Achilles tendon regions, and may also involve the elbows and knees, becoming swollen and whitish upon water immersion; 4. Baseline Physician's Global Assessment (PGA) score >= 2; 5. Patients must be willing to participate and able to provide written informed consent, and voluntarily comply with all protocol requirements; 6. Able to perform daily hand and foot care independently, or have a caregiver to assist; 7. Agree to refrain from engaging in work or activities that may cause severe friction to the hands and feet during the study period;
Exclusion criteria
Exclusion criteria: 1. Use of any of the following medications or therapies within 2 weeks prior to study initiation: topical corticosteroids, keratolytics (e.g., 6% salicylic acid, 70% propylene glycol, 30% urea), retinoids, vitamin D ointments (calcipotriol), tacrolimus, compound lactic acid cream, or gentamicin cream. If any of the above applies, a washout period of at least 2 weeks will be mandatory prior to study initiation. This washout period is intended to minimize any residual effects of prior treatment before starting the study; 2. Use of any of the following medications or therapies within 4 weeks prior to study initiation: oral retinoids, JAK inhibitors (e.g., tofacitinib), methotrexate, cyclosporine, glucocorticoids, or other drugs that may improve erythema and hyperkeratosis. If any of the above applies, a washout period of at least 4 weeks will be mandatory prior to study initiation; 3. Use of benvitimod cream within 4 weeks prior to study initiation; if applicable, a washout period of at least 4 weeks will be required prior to study initiation; 4. Concurrent hand or foot fungal infection prior to enrollment; after the infection has resolved (complete resolution of clinical symptoms caused by fungal infection, such as papulovesicles, maceration and erosion, scaling, etc.; disappearance of pruritus; and negative fungal microscopy results), topical antifungal agents must be discontinued for at least 2 weeks and oral antifungal agents for at least 4 weeks prior to study initiation; 5. Known history of allergy or suspected hypersensitivity reaction to benvitimod cream, or contraindications to any component of benvitimod cream or drugs of a similar nature; 6. Currently participating in another clinical study with the same study objective; 7. Pregnant women, women planning pregnancy, or breastfeeding women; 8. Any other condition deemed by the investigator as unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physician Global Assessment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events occurring during treatment;Changes in skin microbiome;Hospital Anxiety and Depression Scale Anxiety subscale;visual analogue scale;Hyperhidrosis Disease Severity Scale;Patient's Global Assessment;Park and Shin classification system;Dermatology Life Quality Index;Skin photos from baseline to week 32; | — |
Countries
China
Contacts
Public ContactChangxing Li
Dongguan People's Hospital
Outcome results
None listed