Cicatricial AlopeciaNCT06512766
a Retrospective Study on the Systemic Treatment of LPP and FFA
An observational study of Cicatricial Alopecia and Lichen Planopilaris, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cicatricial Alopecia, Lichen Planopilaris, Lichen Plano-Pilaris
- What is being tested?
- Hydroxychloroquine, Methotrexate and Cyclosporine A
- How many people
- 315 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 Sep 2022to 1 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Diagnosis of LPP or FFA
- 18 years or older
Who cannot join
- Other forms of cicatricial alopecia than LPP or FFA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cicatricial Alopecia: a Retrospective Study on the Systemic Treatment of Lichen Planopilaris and Frontal Fibrosing Alopecia
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.
- Conditions
- Cicatricial Alopecia, Lichen Planopilaris, Lichen Plano-Pilaris, Frontal Fibrosing Alopecia, Hair Diseases, Scarring Alopecia
- Being tested
- Hydroxychloroquine, Methotrexate, Cyclosporine A, Retinoids
- Keywords
- Systemic treatment
- Medical subject headings
- Alopecia, Lichen Planus, Hair Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
MethotrexateDrug
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.
Cyclosporine ADrug
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.
RetinoidsDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Hydroxychloroquine; Drug: Methotrexate; Drug: Cyclosporine A; Drug: Retinoids |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start23 Sep 2022
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cicatricial AlopeciaStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DirkJan Hijnen, Erasmus Medical Center
- Investigators
- DirkJan Hijnen, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06512766
- Sponsor's protocol ID
- 9434
- Status last verified
- Jul 2024
- First submitted
- 16 Jul 2024
- Last updated
- 22 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cicatricial Alopecia: a Retrospective Study on the Systemic Treatment of Lichen Planopilaris and Frontal Fibrosing Alopecia
- ClinicalTrials.gov ID
- NCT06512766
- Acronym / sponsor ID
- 9434
- Conditions
- Cicatricial Alopecia, Lichen Planopilaris, Lichen Plano-Pilaris, Frontal Fibrosing Alopecia, Hair Diseases, Scarring Alopecia
- Keywords
- Systemic treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 22 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lichen planopilaris | – | Drug: Hydroxychloroquine, Drug: Methotrexate, Drug: Cyclosporine A, Drug: RetinoidsPatients 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. |
| Frontal fibrosing alopecia | – | Drug: Hydroxychloroquine, Drug: Methotrexate, Drug: Cyclosporine A, Drug: RetinoidsPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Diagnosis of LPP or FFA
- 18 years or older
Key exclusion criteria (1 listed)
- Other forms of cicatricial alopecia than LPP or FFA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydroxychloroquinePatients 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. | Drug | Frontal fibrosing alopecia, Lichen planopilaris |
| MethotrexateThis 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. | Drug | Frontal fibrosing alopecia, Lichen planopilaris |
| Cyclosporine APatients 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. | Drug | Frontal fibrosing alopecia, Lichen planopilaris |
| RetinoidsThis 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. | Drug | Frontal fibrosing alopecia, Lichen planopilaris |
Primary outcome
Treatment response
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.
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).
1 secondary outcome
Reason for discontinuation
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DirkJan Hijnen, MD, PhD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cicatricial Alopecia and Lichen Planopilaris, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment response (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024.