Frontal fibrosing alopecia (FFA) is a type of scarring hair loss that mostly affects women and causes permanent hair loss. Two medicines, hydroxychloroquine (HCQ) and methotrexate (MTX), are often used to treat FFA, but it is not yet clear which treatment works better. This study aims to compare the effects of HCQ and MTX in everyday clinical care.
Adults with FFA who choose to start either HCQ or MTX and will be followed for up to 48 weeks.
The main goal is to see how well each medicine helps reduce disease activity, measured by a tool called the Frontal Fibrosing Alopecia Severity Score (FFASS) after 6 months. At each clinic visit, participants will also complete short questionnaires about symptoms, quality of life, and general well-being.
By collecting this information, the study hopes to provide better evidence about how well HCQ and MTX work for FFA, which may help guide future treatment recommendations.
Age 18 years or older
Diagnosis of frontal fibrosing alopecia (FFA)
Willing and able to provide written informed consent
Adequate understanding of the Dutch language
Histopathological different diagnosis than FFA.
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.
Participants will be recruited from dermatology outpatient clinics at Erasmus MC University Medical Center Rotterdam. The study population consists of adults who have been diagnosed with frontal fibrosing alopecia (FFA) during routine clinical care and are considering systemic treatment with hydroxychloroquine or methotrexate.
Cohort
Prospective
Hydroxychloroquine (HCQ)
Drug400 mg orally once daily
Methotrexate (MTX)
Drug15 mg weekly, orally or subcutaneously (+ concomitant medication: Folic acid 10 mg once weekly, taken 24 hours after MTX)
Frontal Fibrosing Alopecia Severity Score (FFASS) change
The FFASS is a validated scoring system (range 0-25) that captures extent of hairline recession, eyebrow loss, clinical signs of inflammation, and patient symptoms. The primary endpoint is the mean change in FFASS from baseline to 24 weeks, comparing the hydroxychloroquine and methotrexate cohorts.
FFASS change over time
Longitudinal change in disease severity as measured by FFASS across all follow-up visits.
Health-Related Quality of Life (HRQoL)
Change in patient-reported HRQoL measured by Skindex-29 (dermatology-specific).
Health-Related Quality of Life (HRQoL)
Change in patient-reported HRQoL measured by CASIS (hair disease-specific) questionnaire
Adverse Events and Safety
Number, type, and severity of adverse events associated with hydroxychloroquine or methotrexate, as reported during routine care monitoring.
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