Disseminated Superficial Actinic Porokeratosis
Conditions
Interventions
Experimental group:For each subject, the bilateral symmetrical or similar limb regions (such as the left forearm and the right forearm, or the left calf and the right calf) were selected as the target
Control group:For each subject, the bilateral symmetrical or similar limb regions (such as the left forearm and the right forearm, or the left calf and the right calf) were selected as the target area
Sponsors
Dermatology Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
25 Years to 65 Years
Inclusion criteria
Inclusion criteria: Subject must meet all of the following criteria to be enrolled: 1) Age between 25 and 65 years, regardless of gender; 2) Clinical diagnosis of Disseminated Superficial Actinic Porokeratosis (DSAP), with symmetrical or similar lesions on bilateral limbs (e.g., both forearms or both lower legs); 3) Genetic testing confirming a mutation in the mevalonate synthesis pathway gene; 4) Five or more target lesions per side in the target area of each limb. 5) Inadequate response (defined as less than 50% improvement after continuous and regular use for =8 weeks), intolerance, or refusal to previous conventional topical treatments (such as topical retinoids, 5-fluorouracil, salicylic acid, etc.) or local destructive therapies (e.g., cryotherapy, laser, surgery). 6) Agreement to complete at least a 4-week washout period before the baseline visit (V0), during which any topical active medications (e.g., retinoids, 5-fluorouracil, etc.) and any systemic treatments that may affect the condition are discontinued in the target lesion areas. 7) Declaration of willingness to comply with the protocol and voluntary signing of the informed consent form.
Exclusion criteria
Exclusion criteria: 1) Allergy to statins or any excipients of the cream.? 2) Presence of open wounds or active infection in the target area.? 3) Use of any topical active medications (including but not limited to retinoids, 5-fluorouracil, vitamin D derivatives, immunomodulators, etc.) in the target area within 4 weeks before the baseline visit (V0).? 4) Receipt of any systemic treatment for DSAP (such as oral retinoids, immunosuppressants) or any form of local destructive therapy (e.g., cryotherapy, laser, photodynamic therapy) within 8 weeks before the baseline visit (V0).? 5) Use of any systemic immunomodulators or biologics for other diseases within 12 weeks before the baseline visit (V0).? 6) Pregnant or lactating women.? 7) Coexisting severe systemic diseases or conditions deemed unsuitable for participation by the investigator, including but not limited to: severe hepatic or renal insufficiency (defined as ALT/AST > 2 times the upper limit of normal, or creatinine clearance < 60 mL/min).? 8) Any condition judged by the investigator as likely to interfere with study evaluation, increase subject risk, or affect compliance (e.g., intense sun exposure during the trial period).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage decrease from baseline in the total DSAP-GASI score at Week 6; | — |
Secondary
| Measure | Time frame |
|---|---|
| The absolute change from baseline in the total DSAP-GASI score at Week 6;The change from baseline in the DLQI quality of life score at Week 6;Patient-Reported Outcomes (PRO): Changes in lesion appearance, color, size, as well as pain and itching;Safety indicators: Local adverse events (e.g., erythema, burning sensation.Systemic safety indicators: Liver and kidney function, blood lipids.; | — |
Countries
China
Contacts
Public ContactLin Zhimiao
Dermatology Hospital of Southern Medical University
Outcome results
None listed