An observational study in Lichen Planopilaris and Cicatricial Alopecia, sponsored by Erasmus Medical Center. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-07-22.
Sponsored by Erasmus Medical Center · Observational
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.
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 measures. Currently, the treatment goal for LPP primarily focuses on halting disease progression to minimize further hair loss and alleviate associated symptoms. Treatment options for LPP include topical/intralesional corticosteroids, and systemic therapies such as hydroxychloroquine (HCQ), methotrexate (MTX), and other immunosuppressive agents. However, the absence of daily practice studies makes it challenging to establish therapeutic recommendations.
This patient preferred trial aims to fill a crucial knowledge gap in LPP management. Existing evidence lacks comprehensive guidelines for treating LPP effectively, leaving current approaches largely empirical. Aligning with the urgent need for answers highlighted by the 'Nederlandse Vereniging voor Dermatologie en Venereologie Kennisagenda Dermatologie 2019': 'Q9 - Wat is de effectiviteit van systemische behandeling bij patiënten met cicatriciële alopeciëen?' (What is the most effective systemic treatment for cicatricial alopecias) (13) underscores the pressing concern regarding the effectiveness of systemic therapy in cicatricial alopecia. This study seeks to contribute novel insights to the field by comparing the effectiveness of the two most commonly used systemic treatments, HCQ and MTX in treating LPP. By comparing the effectiveness and safety profiles of these systemics, this study endeavours to provide valuable information that can guide evidence-based treatment decisions and enhance the overall understanding of LPP management.
Objective(s)
The main objective is to assess the effectiveness in routine clinical care of hydroxychloroquine (HCQ) and methotrexate (MTX) in the treatment of adults diagnosed with lichen planopilaris (LPP) by evaluating the impact on the Lichen Planopilaris Activity Index (LPPAI) after a 6-month treatment period.
Primary objective:
To investigate the difference in LPPAI between baseline and 24 weeks of treatment between the HCQ and MTX group
Secondary objectives:
Skindex-29
The Skindex-29 is a dermatology-specific questionnaire. It evaluates the effect of skin conditions on physical, psychological, and social aspects. It assesses the extent to which a skin condition has influenced quality of life over the past week. The 29 questions are divided into 3 domains: symptoms, emotions, and functioning. A higher score corresponds to a greater impact on quality of life.
Other disease- and treatment-related characteristics will be retrieved from the electronic patient records.
74 studies on the registry are indexed under Lichen Planus; 15 are open to participants now.
This study's planned enrollment of 56 is below the median of 80 across 17 observational studies indexed under Lichen Planus.
Browse Lichen Planus studies →Erasmus Medical Center is the lead sponsor of 478 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All adult (≥18 years) patients diagnosed with LPP. All patients will be recruited at the dermatology outpatient clinics in the Erasmus University Medical Center.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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)
or allergy to MTX
Lung toxicity due to MTX or significant reduction in lung function.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HCQ is administered orally at a dosage of 400 mg daily.
Drug: Hydroxychloroquine
MTX is given at a dose of 15 mg per week, orally or subcutaneously. Additionally, folate supplementation is administered concurrently as part of standard care, with folate 10 mg/week administered 24 hours after MTX intake.
Drug: Methotrexate
HCQ (15) is administered orally at a dosage of 400 mg daily.
MTX (16) is given at a dose of 15 mg per week, orally or subcutaneously. Additionally, folate supplementation is administered concurrently as part of standard care, with folate 10 mg/week administered 24 hours after MTX intake.
LPPAI
The main study parameter is the change in Lichen PlanoPilaris Activity Index (LPPAI) measured at 6 months (0-10).
Time frame: at 24 weeks
LPPAI
The main study parameter is the change in Lichen PlanoPilaris Activity Index (LPPAI) measured (0-10).
Time frame: at 0, 12, 36, 48 weeks
Skindex-29
Quality of Life
Time frame: at 0, 12, 24, 36, 48 weeks
Side effects
Number of side effects
Time frame: at 0, 12, 24, 36, 48 weeks
Plan to share: Undecided — Undecided
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.