Autosomal Recessive Hypotrichosis Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Erasmus MC
RECRUITING
Rotterdam
Contact Information
Primary
Mathias Willaert, MD
HEMLET@erasmusmc.nl
(010) 704 01 10
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 56
Treatments
Hydroxychloroquine (HCQ)
HCQ is administered orally at a dosage of 400 mg daily.
Methotrexate (MTX)
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.
Related Therapeutic Areas
Sponsors
Leads: Erasmus Medical Center

This content was sourced from clinicaltrials.gov