Actively Recruiting
The Effectiveness of Hydroxychloroquine Versus Methotrexate in the Treatment of Lichen Planopilaris in Routine Clinical Care: a Patient Preference Trial
Led by Erasmus Medical Center · Updated on 2024-07-22
56
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Lichen planopilaris (LPP) is a common type of scarring hair loss mainly affecting adults and causing permanent hair loss. This research compares two commonly used treatments, hydroxychloroquine (HCQ) and methotrexate (MTX), to better understand their effectiveness in routine clinical practice. The study focuses on adults diagnosed with LPP and evaluates how these treatments impact the disease over time. Participants select either HCQ, taken orally at 400 mg daily, or MTX, given at 15 mg weekly either orally or by injection, along with weekly folate supplements. The study lasts up to 48 weeks following patient preference without random assignment. Treatment progress is monitored through regular clinical care visits aligned with standard practice. During the study, patients will have their disease activity measured by the Lichen Planopilaris Activity Index (LPPAI) at several time points, particularly at 24 weeks. Quality of life will be assessed using the Skindex-29 questionnaire at each visit. Researchers will also track side effects and treatment discontinuation rates. Data from patient records will be collected to support the study findings.
CONDITIONS
Brief Title
The Effectiveness of Hydroxychloroquine Versus Methotrexate in the Treatment of Lichen Planopilaris in Routine Clinical Care: a Patient Preference Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age of 18 years and older
- Diagnosed with lichen planopilaris (LPP)
- Willingness to provide informed consent for participation in the study
- No contraindications or known allergies to hydroxychloroquine (HCQ) or methotrexate (MTX)
You will not qualify if you...
- Histopathological diagnosis other than lichen planopilaris (LPP)
- Inability to follow the study protocol, including medication intake, clinic visits, and questionnaire completion
- Contraindications to hydroxychloroquine (HCQ), such as retinopathy, maculopathy, myasthenia gravis, or body weight less than 35 kg
- Contraindications to methotrexate (MTX), including conception or lactation, severe kidney or liver dysfunction, alcohol abuse, bone marrow hypoplasia, immunodeficiency, anemia, leukopenia, thrombocytopenia, poor nutritional status, allergy to MTX, lung toxicity, or significant lung function reduction
- Patients ineligible for one treatment arm will be assigned to the other treatment arm automatically
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 48 weeks
Participants receive treatment with either hydroxychloroquine or methotrexate to manage lichen planopilaris and are monitored for effectiveness and side effects.
Visits at 0, 12, 24, 36, and 48 weeks for assessments
Trial Site Locations
Total: 1 location
1
Erasmus MC
Rotterdam, South Holland, Netherlands, 3015GD
Actively Recruiting
Research Team
M
Mathias Willaert, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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