Status:
RECRUITING
The Effectiveness of Hydroxychloroquine Versus Methotrexate in the Treatment of Lichen Planopilaris in Routine Clinical Care: a Patient Preference Trial
Lead Sponsor:
Erasmus Medical Center
Conditions:
Lichen Planopilaris
Cicatricial Alopecia
Eligibility:
All Genders
18-80 years
Brief Summary
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 t...
Detailed Description
Treatment of LPP remains a challenge due to limited evidence-based guidelines and a lack of randomized controlled trials, leading to the absence of standardized therapeutic protocols and outcome measu...
Eligibility Criteria
Inclusion
- Age of 18 years and older.
- Diagnosed with LPP.
- Willingness to provide informed consent for participation in the study.
- No contraindications or known allergies to HCQ or MTX.
Exclusion
- Histopathological different diagnosis than LPP.
- 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.
- \- Contraindications MTX:
- Conception (both male and female) and lactation
- Severe kidney or liver dysfunction (fibrosis, cirrhosis) or alcohol abuse
- Bone marrow hypoplasia, immunodeficiency
- Anemia, leukopenia, or thrombocytopenia
- Poor nutritional status (low albumin)
- Hypersensitivity or allergy to MTX
- Lung toxicity due to MTX or significant reduction in lung function.
Key Trial Info
Start Date :
July 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2026
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT06512753
Start Date
July 1 2024
End Date
July 1 2026
Last Update
July 22 2024
Active Locations (1)
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1
Erasmus MC
Rotterdam, South Holland, Netherlands, 3015GD