Rationale Lichen planopilaris (LPP) is a prevalent form of cicatricial alopecia, predominantly affecting women and causing irreversible hair loss. Hydroxychloroquine (HCQ) and methotrexate (MTX) are the most frequently used systemics for treatment of LPP in daily practice. Due to the absence of well-established treatment guidelines, this study aims to evaluate the effectiveness of HCQ and MTX in routine clinical care.
Objective(s) To investigate the effectiveness of HCQ and MTX in the treatment of adults with lichen planopilaris in routine clinical care.
Study type Prospective, patient preference clinical trial with a duration up to 48 weeks in accordance with the routine clinical care guidelines.
Study population This study will include adults (≥18 years) diagnosed with LPP.
Methods Patients will choose between HCQ and MTX treatment as in routine clinical care, receiving follow-up in accordance with standard clinical practices. They will not be randomized. The primary endpoint is the measurement of the Lichen Planopilaris Activity Index (LPPAI) at the 6-months, providing a quantitative assessment of the disease's activity and response to the selected treatment. The Skindex-29 questionnaire will be conducted at each visit, allowing evaluation of the impact on patients' quality of life.
Age of 18 years and older.
Diagnosed with LPP.
Willingness to provide informed consent for participation in the study.
No contraindications or known allergies to HCQ or MTX.
Histopathological different diagnosis than LPP.
Inability to adhere to the study protocol, including medication intake, clinic visits, and questionnaire completion.
Patients who are ineligible for the HCQ arm (due to contraindications), are automatically included in the MTX arm.
All adult (≥18 years) patients diagnosed with LPP. All patients will be recruited at the dermatology outpatient clinics in the Erasmus University Medical Center.
Cohort
Prospective
Hydroxychloroquine
DrugHCQ (15) is administered orally at a dosage of 400 mg daily.
Methotrexate
DrugMTX (16) is given at a dose of 15 mg per week, orally or subcutaneously. Additionally, folate supplementation is administered concurrently as part of standard care, with folate 10 mg/week administered 24 hours after MTX intake.
LPPAI
The main study parameter is the change in Lichen PlanoPilaris Activity Index (LPPAI) measured at 6 months (0-10).
LPPAI
The main study parameter is the change in Lichen PlanoPilaris Activity Index (LPPAI) measured (0-10).
Skindex-29
Quality of Life
Side effects
Number of side effects
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