The Effectiveness of Hydroxychloroquine Versus Methotrexate in the Treatment of Frontal Fibrosing Alopecia in Routine Clinical Care: a Patient Preference Trial (FFA Trial)

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorErasmus Medical Center

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Hydroxychloroquine (HCQ)
  • Methotrexate (MTX)

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators