Palmoplantar Pustulosis
Conditions
Interventions
Self-controlled treatment group:Topical crisaborole ointment, twice daily, for 8 weeks of use.
Self-controlled group:Topical mometasone ointment, twice daily, for 8 weeks of use.
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–75 years, both genders eligible; 2. Meeting the diagnostic criteria for palmoplantar pustulosis as defined in the Chinese Expert Consensus on the Diagnosis and Treatment of Pustular Psoriasis (2022 Edition); 3. Baseline PPPASI score difference between bilateral affected areas = 2 points; 4. No use of topical glucocorticoids, vitamin D3 derivatives, calcineurin inhibitors, topical Chinese herbal medicines (e.g., lotions, ointments, occlusive dressings, etc.), or other topical medications that may affect efficacy on the target areas (palms and soles) within 2 weeks prior to screening; 5. Voluntarily sign the informed consent form and be able to comply with follow-up, medication, and evaluations; 6. Prior or current systemic treatments (including but not limited to oral medications, biologics, small molecule drugs, etc.), phototherapy, or topical moisturizers are not exclusion criteria; no washout period is required before enrollment, provided that the dose and frequency of the above background treatment regimens remain relatively stable during the study period. The biological agents and small molecule drugs still show poor efficacy after being used for 3 months.
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to any ingredient of crisaborole ointment or mometasone furoate cream; 2. Concomitant severe systemic diseases (e.g., severe liver or kidney dysfunction, autoimmune diseases, etc.); 3. Concomitant uncontrolled bacterial, fungal, or viral infection; 4. Pregnant or breastfeeding women; 5. Concurrent participation in another clinical study; 6. History of drug abuse or psychiatric disorders that prevents compliance with study procedures; 7. Presence of ulceration, erosion, or severe skin damage at the lesion sites that precludes topical drug application; 8. Use of the following topical treatments on the target areas (palms and soles) within 2 weeks prior to screening: Topical glucocorticoids (e.g., halobetasol, betamethasone, etc.); Topical vitamin D3 derivatives (e.g., calcipotriol, etc.); Topical Chinese herbal preparations (e.g., herbal fumigation and washing, liniments, plasters, occlusive therapy, etc.); Calcineurin inhibitors (e.g., tacrolimus, etc.) or other topical active ingredient medications.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The absolute value of the decrease in PPASI scores from baseline between the experimental group and the control group at week 8;The proportion of patients with an improvement rate of ?50% in PPPASI score at week 8, calculated on a per unilateral lesion site basis;The proportion of PGA0/1 (clear or almost clear) at week 8;DLQI quality of life score, assessing the improvement of quality of life before and after treatment;The proportion of patients with a bilateral lesion site PPVASI score increase of ?50% compared to the end of treatment at week 12; | — |
Primary
| Measure | Time frame |
|---|---|
| Improvement rate of PPPASI score from baseline at week 8; | — |
Countries
China
Contacts
Public ContactJuan Du
Huashan Hospital, Fudan University
Outcome results
None listed