The Effectiveness of Hydroxychloroquine Versus Methotrexate in the Treatment of Frontal Fibrosing… (NCT07190534) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
The Effectiveness of Hydroxychloroquine Versus Methotrexate in the Treatment of Frontal Fibrosing Alopecia in Routine Clinical Care: a Patient Preference Trial (FFA Trial)
Netherlands50 participantsStarted 2025-11
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
* No known contraindications or allergies to hydroxychloroquine (HCQ) or methotrexate (MTX)
Exclusion Criteria:
* 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.
Contraindications HCQ: retinopathy and/or maculopathy/myasthenia gravis/body weight less than 35 kg
\- Patients who are ineligible for the MTX arm (due to contraindications), are automatically included in the HCQ arm.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.