Linear Porokeratosis
Conditions
Interventions
Self-control group:1. Intervention Design
This study employs a single-center, randomized, double-blind, split-lesion, within-patient controlled design. A single continuous linear lesion of linear po
Sponsors
Dermatology Hospital of Southern Medical University
Eligibility
Sex/Gender
All
Age
5 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Allergy to statins or any excipients in creams; 2. There are open wounds or active infections in the target area; 3. Within 4 weeks before the baseline visit (V0), any topical active drugs (including but not limited to retinoids, 5-fluorouracil, vitamin D derivatives, immunomodulators, etc.) were used in the target area; 4. Within 8 weeks prior to the baseline visit (V0), any systemic treatment for LP (such as oral tretinoin, immunosuppressants) or any form of local destructive treatment (such as cryotherapy, laser therapy, photodynamic therapy) was received; 5. Within 12 weeks prior to the baseline visit (V0), any systemic immunomodulators or biologics were used for other diseases; 6. Pregnant or lactating women; 7. Those with severe systemic diseases or those deemed unsuitable for participation by the researchers, including but not limited to: severe liver or kidney insufficiency (defined as ALT/AST > 2 times the upper limit of the normal value, or creatinine clearance rate < 60 mL/min); 8. The researcher determines that the subject has any circumstances that may interfere with the research evaluation, increase the subject's risk or affect their compliance (such as high-intensity sun exposure during the trial, etc.).
Exclusion criteria
Exclusion criteria: 1. Allergy to statins or any excipients in creams; 2. There are open wounds or active infections in the target area; 3. Within 4 weeks before the baseline visit (V0), any topical active drugs (including but not limited to retinoids, 5-fluorouracil, vitamin D derivatives, immunomodulators, etc.) were used in the target area; 4. Within 8 weeks prior to the baseline visit (V0), any systemic treatment for LP (such as oral tretinoin, immunosuppressants) or any form of local destructive treatment (such as cryotherapy, laser therapy, photodynamic therapy) was received; 5. Within 12 weeks prior to the baseline visit (V0), any systemic immunomodulators or biologics were used for other diseases; 6. Pregnant or lactating women; 7. Those with severe systemic diseases or those deemed unsuitable for participation by the researchers, including but not limited to: severe liver or kidney insufficiency (defined as ALT/AST > 2 times the upper limit of the normal value, or creatinine clearance rate < 60 mL/min); 8. The researcher determines that the subject has any circumstances that may interfere with the research evaluation, increase the subject's risk or affect their compliance (such as high-intensity sun exposure during the trial, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage decrease from baseline in the total LP-specific score at Week 6.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The absolute change in LP-specific scores in the 6th week;Patient-reported outcome (PRO) : Changes in the appearance, color, and size of the lesion, as well as changes in pain and pruritus.;Safety indicators: Local adverse events (such as erythema, burning sensation); Systemic safety indicators: liver and kidney functions, blood lipids; | — |
Countries
China
Contacts
Public ContactLin Zhimiao
Dermatology Hospital of Southern Medical University
Outcome results
None listed