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
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Rationale Lichen planopilaris (LPP) is a prevalent form of cicatricial alopecia, predominantly affecting women and causing irreversible hair loss. Hydroxychloroquine (HCQ) and methotrexate (MTX) are the most frequently used systemics for treatment of LPP in daily practice. Due to the absence of well-established treatment guidelines, this study aims to evaluate the effectiveness of HCQ and MTX in routine clinical care. Objective(s) To investigate the effectiveness of HCQ and MTX in the treatment of adults with lichen planopilaris in routine clinical care. Study type Prospective, patient preference clinical trial with a duration up to 48 weeks in accordance with the routine clinical care guidelines. Study population This study will include adults (≥18 years) diagnosed with LPP. Methods Patients will choose between HCQ and MTX treatment as in routine clinical care, receiving follow-up in accordance with standard clinical practices. They will not be randomized. The primary endpoint is the measurement of the Lichen Planopilaris Activity Index (LPPAI) at the 6-months, providing a quantitative assessment of the disease's activity and response to the selected treatment. The Skindex-29 questionnaire will be conducted at each visit, allowing evaluation of the impact on patients' quality of life.
CONDITIONS
Official 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 or methotrexate.
You will not qualify if you...
- Histopathological diagnosis other than Lichen Planopilaris (LPP).
- Unable to adhere to the study protocol, including medication intake, clinic visits, and questionnaire completion.
- Contraindications for hydroxychloroquine including retinopathy, maculopathy, myasthenia gravis, or body weight less than 35 kg.
- Contraindications for methotrexate including conception or lactation, severe kidney or liver dysfunction, alcohol abuse, bone marrow hypoplasia, immunodeficiency, anemia, leukopenia, thrombocytopenia, poor nutritional status, hypersensitivity to methotrexate, lung toxicity, or significant lung function reduction.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Erasmus MC
Rotterdam, South Holland, Netherlands, 3015GD
Actively Recruiting
Research Team
M
Mathias Willaert, MD
CONTACT
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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