Comparing Hydroxychloroquine and Methotrexate for Treating Lichen Planopilaris
The Effectiveness of Hydroxychloroquine Versus Methotrexate in the Treatment of Lichen Planopilaris in Routine Clinical Care: a Patient Preference Trial
This study is testing whether hydroxychloroquine or methotrexate works better for adults with lichen planopilaris, a condition that causes hair loss.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 56 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Erasmus Medical Center Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Rotterdam, South Holland) |
| Trial ID | NCT06512753 on ClinicalTrials.gov |
What this trial studies
This observational trial investigates the effectiveness of hydroxychloroquine (HCQ) versus methotrexate (MTX) in treating adults diagnosed with lichen planopilaris (LPP), a form of cicatricial alopecia that leads to irreversible hair loss. Patients will choose their preferred treatment option and receive follow-up care according to standard clinical practices over a duration of up to 48 weeks. The study aims to address the lack of established treatment guidelines for LPP by providing insights into the effectiveness of these commonly used systemic therapies in routine clinical care.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years and older who have been diagnosed with lichen planopilaris and are willing to provide informed consent.
Not a fit: Patients with a different histopathological diagnosis than LPP or those unable to adhere to the study protocol may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable evidence to guide treatment decisions for patients with lichen planopilaris, potentially improving their quality of life.
How similar studies have performed: While there is limited evidence from randomized controlled trials, this study aims to fill a significant gap in knowledge regarding the effectiveness of systemic treatments for cicatricial alopecia, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Rotterdam, South Holland
- Erasmus MC — Rotterdam, South Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: DirkJan Hijnen, MD, PhD — Erasmus Medical Center
- Study coordinator: Mathias Willaert, MD
- Email: HEMLET@erasmusmc.nl
- Phone: (010) 704 01 10
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.