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

NCT06512753 | Recruiting FDA Drug

• 1 other identifier: 11940
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lichen Planopilaris; Cicatricial Alopecia

Keywords

Lichen planopilaris; Cicatricial alopecia; Hydroxychloroquine; Methotrexate

Outcome Measures

Primary Outcomes (1)

• LPPAI

  The main study parameter is the change in Lichen PlanoPilaris Activity Index (LPPAI) measured at 6 months (0-10).

  at 24 weeks

Secondary Outcomes (3)

• LPPAI

  at 0, 12, 36, 48 weeks

• Skindex-29

  at 0, 12, 24, 36, 48 weeks

• Side effects

  at 0, 12, 24, 36, 48 weeks

Study Arms (2)

Hydroxychloroquine (HCQ)

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

Drug: Hydroxychloroquine

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.

Drug: Methotrexate

Interventions

Hydroxychloroquine DRUG

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

Hydroxychloroquine (HCQ)

Methotrexate DRUG

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.

Methotrexate (MTX)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult (≥18 years) patients diagnosed with LPP. All patients will be recruited at the dermatology outpatient clinics in the Erasmus University Medical Center.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3015GD, Netherlands

RECRUITING

MeSH Terms

Conditions

Lichen Planus; Alopecia

Interventions

Hydroxychloroquine; Methotrexate

Condition Hierarchy (Ancestors)

Lichenoid Eruptions; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Hypotrichosis; Hair Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Aminopterin; Pterins; Pteridines

Study Officials

• DirkJan Hijnen, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mathias Willaert, MD

CONTACT

(010) 704 01 10; HEMLET@erasmusmc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 22, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

NL (1)