a Retrospective Study on the Systemic Treatment of LPP and FFA

NCT06512766 | Completed

• 1 other identifier: 9434
• Study Type: observational
• Target: 315
• Locations: 1 country
• Sites: 1

Brief Summary

This retrospective study aims to assess the effectiveness of systemic treatments for lichen planopilaris (LPP) and frontal fibrosing alopecia (FFA) in patients treated at the Erasmus MC University Medical Center. LPP and FFA are chronic inflammatory hair disorders leading to irreversible hair loss. The study evaluates treatment responses to systemic medications, including hydroxychloroquine, methotrexate, cyclosporine A, and retinoids.

Conditions

Cicatricial Alopecia; Lichen Plano-Pilaris; Frontal Fibrosing Alopecia; Hair Diseases; Scarring Alopecia; Hair Loss/Baldness

Keywords

Systemic treatment

Outcome Measures

Primary Outcomes (1)

• Treatment response

  The primary outcome measure is the treatment response of systemic treatment options in patients diagnosed with LPP and FFA. Treatment response is categorized into three groups: no response (progression of symptoms, hair loss, and trichoscopic activity), moderate response (improvement in symptoms, reduced hair loss progression, or reduction in trichoscopic activity), and good response (absence of symptoms, no further hair loss, and no trichoscopic activity).

  The time frame for evaluating treatment response varies per patient due to the retrospective nature of the study. Patients were treated and assessed at various intervals between July 2016 and July 2022.

Secondary Outcomes (1)

• Reason for discontinuation

  The time frame for evaluating reason for discontinuation varies per patient due to the retrospective nature of the study. Patients were treated and assessed at various intervals between July 2016 and July 2022.

Study Arms (2)

Lichen planopilaris

Patients in this group were diagnosed and treated for lichen planopilaris (LPP), a form of primary lymphocytic cicatricial alopecia. Treatment options included hydroxychloroquine (HCQ), methotrexate (MTX), cyclosporine A (CsA), and retinoids. The effectiveness of these treatments varied among patients. Due to the retrospective nature of the study, the dosage form, dosage, frequency, and duration of treatments were not consistent.

Drug: Hydroxychloroquine; Drug: Methotrexate; Drug: Cyclosporine A; Drug: Retinoids

Frontal fibrosing alopecia

Patients in this group were diagnosed and treated for frontal fibrosing alopecia (FFA), a form of primary lymphocytic cicatricial alopecia. Treatment options included hydroxychloroquine (HCQ), methotrexate (MTX), cyclosporine A (CsA), and retinoids. The effectiveness of these treatments varied among patients. Due to the retrospective nature of the study, the dosage form, dosage, frequency, and duration of treatments were not consistent.

Drug: Hydroxychloroquine; Drug: Methotrexate; Drug: Cyclosporine A; Drug: Retinoids

Interventions

Hydroxychloroquine DRUG

Patients in this group were treated with hydroxychloroquine (HCQ), a systemic medication commonly used as a first-line treatment due to its ease of use and established safety profile. Due to the retrospective nature of the study, the dosage form, dosage, frequency, and duration of treatments varied among patients.

Frontal fibrosing alopecia; Lichen planopilaris

Methotrexate DRUG

This group consists of patients treated with methotrexate (MTX), a systemic medication often used as a second-line treatment for its effectiveness in reducing inflammation and controlling autoimmune responses. Due to the retrospective nature of the study, the dosage form, dosage, frequency, and duration of treatments varied among patients.

Frontal fibrosing alopecia; Lichen planopilaris

Cyclosporine A DRUG

Patients in this group were treated with cyclosporine A (CsA), a potent immunosuppressive agent used for its effectiveness in controlling severe inflammatory responses. Due to the retrospective nature of the study, the dosage form, dosage, frequency, and duration of treatments varied among patients.

Frontal fibrosing alopecia; Lichen planopilaris

Retinoids DRUG

This cohort includes patients treated with retinoids, which are used for their ability to modulate cell growth and differentiation. Due to the retrospective nature of the study, the dosage form, dosage, frequency, and duration of treatments varied among patients.

Frontal fibrosing alopecia; Lichen planopilaris

Eligibility Criteria

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

Study Population

All patients diagnosed with International Classification of Diseases and Related Health Problems, Tenth Revision (ICD-10) diagnosis: L66 cicatricial alopecia, between July 2016 and July 2022, from the Department of Dermatology, Erasmus MC University Medical Center, were included.

You may qualify if:

• Diagnosis of LPP or FFA
• years or older

You may not qualify if:

• Other forms of cicatricial alopecia than LPP or FFA

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus MC

Rotterdam, South Holland, 3015GD, Netherlands

Location

MeSH Terms

Conditions

Alopecia; Lichen Planus; Hair Diseases

Interventions

Hydroxychloroquine; Methotrexate; Cyclosporine; Retinoids

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Aminopterin; Pterins; Pteridines; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• DirkJan Hijnen, MD, PhD

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• 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: September 23, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

NL (1)