porokeratosis ptychotropica
Conditions
Interventions
single component drug group:2% simvastatin cream for external use on the skin lesions of the test side, and placebo for external use on the other side, twice a day
multi-component drug group:2% simvastatin/2% cholesterol cream for external use on the skin lesions of the test side, and placebo for external use on the other side
Sponsors
Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years old, no gender limitation; 2. The diagnosis of porokeratosis ptychotropica: (1) Clinical: bilateral symmetric patterns of verrucous hyperplasia plaques on buttocks (above 5cm in diameter), with or without pruritus; (2) Pathological: show cornoid lamella in pathological examination. If the patient has done pathological examination, submit the report without repeated examination; (3) Genetic: detect the heterozygous mutation of mevalonate pathway genes (including MVK, PMVK, MVD, FDPS) using blood. If the patient has done gene analysis, submit the report without repeated analysis; 3. Agree to use effective contraceptives during the study and 3 months after the trial finished in the patients of childbearing age.
Exclusion criteria
Exclusion criteria: 1. The allergy or side effects history of statins; 2. Treatment with cryotherapy, laser therapy, grinding, oral or topical acitretin, topical 5-FU, imiquimod and tacrolimus within 4 weeks; 3. Potential canceration or pathological diagnosis of canceration; 4. Participated in other interventional clinical trials within 3 months; 5. Important organ dysfunction: liver or kidney dysfunction, cardio-cerebrovascular disease, kidney dysfunction, etc.; 6. Acute infection or chronic active infection; 7. Pregnant or lactating female; 8. Any situation that the researchers consider may affect research participation or confuse the results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| lesion area;erythema degree;scale degree;lesion thickness; | — |
Secondary
| Measure | Time frame |
|---|---|
| pruritus visual analogue scale; | — |
Countries
China
Contacts
Public ContactYong Yang
Institute of Dermatology, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed