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

NCT07190534 | Not Yet Recruiting

• 1 other identifier: 14475
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Frontal Fibrosing Alopecia; Cicatricial Alopecia

Keywords

Frontal fibrosing alopecia; FFA; Cicatricial alopecia; Scarring alopecia; Hair disease; hydroxychloroquine; methotrexate

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 24 weeks

Secondary Outcomes (7)

• FFASS change over time

  Baseline, Weeks 12, 24, 36, and 48

• Health-Related Quality of Life (HRQoL)

  Baseline, Weeks 12, 24, 36, and 48

• Health-Related Quality of Life (HRQoL)

  Baseline, Weeks 12, 24, 36, and 48

• Adverse Events and Safety

  Baseline through Week 48

• Cost-Effectiveness and Health Economic Outcomes

  Baseline and Week 24

Study Arms (2)

Hydroxychloroquine group

Intervention: hydroxychloroquine

Drug: Hydroxychloroquine (HCQ)

Methotrexate group

Intervention: methotrexate

Drug: Methotrexate (MTX)

Interventions

Hydroxychloroquine (HCQ) DRUG

400 mg orally once daily

Also known as: Plaquenil

Hydroxychloroquine group

Methotrexate (MTX) DRUG

15 mg weekly, orally or subcutaneously (+ concomitant medication: Folic acid 10 mg once weekly, taken 24 hours after MTX)

Also known as: MTX

Methotrexate group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC University Medical Center

Rotterdam, South Holland, 3015GD, Netherlands

Location

MeSH Terms

Conditions

Alopecia; Hair Diseases

Interventions

Hydroxychloroquine; Methotrexate

Condition Hierarchy (Ancestors)

Hypotrichosis; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Aminopterin; Pterins; Pteridines

Central Study Contacts

Mathias Willaert, MD

CONTACT

+31 10 704 01 10; FFA@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 24, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

NL (1)