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CompletedNCT06512766Updated Jul 22, 2024

a Retrospective Study on the Systemic Treatment of LPP and FFA

An observational study in Cicatricial Alopecia, Lichen Planopilaris and Lichen Plano-Pilaris, sponsored by Erasmus Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-22.

Sponsored by Erasmus Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
315
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed description

Cicatricial alopecia, also known as scarring alopecia, refers to a group of rare chronic inflammatory hair disorders resulting in irreversible hair loss. Lichen planopilaris (LPP) and frontal fibrosing alopecia (FFA) are the most common forms of primary lymphocytic cicatricial alopecia, affecting predominantly postmenopausal women. These conditions lead to significant quality of life impairment due to their chronic nature and the lack of effective, standardized treatment protocols. The study aimed to address the gap in evidence-based treatment guidelines by investigating the effectiveness of various systemic therapies currently used in clinical practice. The retrospective cohort study reviewed medical records of patients diagnosed with LPP or FFA at the Department of Dermatology, Erasmus MC University Medical Center, from July 2016 to July 2022.

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Conditions studied

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

Keywords

  • Systemic treatment
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In context

Alopecia

511 studies on the registry are indexed under Alopecia; 128 are open to participants now.

This study's enrollment of 315 is above the median of 95 across 52 observational studies indexed under Alopecia.

Browse Alopecia studies →

Lead sponsor

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.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

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.

Inclusion criteria

  • Diagnosis of LPP or FFA
  • 18 years or older

Exclusion criteria

Exclusion Criteria:

  • Other forms of cicatricial alopecia than LPP or FFA
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
315 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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.

  • 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.

  • 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.

  • DrugRetinoids

    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.

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What researchers measure

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).

    Time frame: 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

    This secondary outcome measure assesses the discontinuation rates of systemic treatments (HCQ, MTX, CsA, and retinoids) and the reasons for discontinuation, such as side effects or insufficient treatment effects.

    Time frame: 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.

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Study locations

1 site
  • Erasmus MC
    Rotterdam, Zuid-Holland 3015GD, Netherlands
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06512766
Responsible party
DirkJan Hijnen (MD, PhD, Erasmus Medical Center) — Principal investigator
First posted
Jul 22, 2024
Start date
Sep 23, 2022
Primary completion
Feb 1, 2023
Completion
Feb 1, 2023
Last update
Jul 22, 2024

Study contacts

DirkJan Hijnen, MD, PhD
principal investigator · Erasmus Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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