The Effectiveness of Hydroxychloroquine Versus Methotrexate in the Treatment of Lichen Planopilar… (NCT06512753) | Clinical Trial Compass
RecruitingNot Applicable
The Effectiveness of Hydroxychloroquine Versus Methotrexate in the Treatment of Lichen Planopilaris in Routine Clinical Care: a Patient Preference Trial
Netherlands56 participantsStarted 2024-07-01
Plain-language 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 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.