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RecruitingNCT06512753

The Effectiveness of Hydroxychloroquine Versus Methotrexate in the Treatment of Lichen Planopilaris in Routine Clinical Care: a Patient Preference Trial

Sponsor

Erasmus Medical Center

Enrollment

56 participants

Start Date

Jul 1, 2024

Study Type

OBSERVATIONAL

Conditions

Lichen PlanopilarisCicatricial Alopecia

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

  • 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 Criteria16

  • 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.

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Interventions

DRUGHydroxychloroquine

HCQ (15) is administered orally at a dosage of 400 mg daily.

DRUGMethotrexate

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.

Locations(1)

Erasmus MC

Rotterdam, South Holland, Netherlands

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NCT06512753