Lichen PlanopilarisHEMLETNCT06512753
The Effectiveness of Hydroxychloroquine Versus Methotrexate in the Treatment of Lichen Planopilaris in Routine Clinical Care: a Patient Preference Trial
An observational study of Lichen Planopilaris and Cicatricial Alopecia, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lichen Planopilaris, Cicatricial Alopecia
- What is being tested?
- Hydroxychloroquine and Methotrexate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 56 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jul 2024to 1 Jul 2026
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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
- Lung toxicity due to MTX or significant reduction in lung function.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus MC
Rotterdam, South Holland, 3015GD
Mathias Willaert, MD, (010) 704 01 10, HEMLET@erasmusmc.nl
Mathias Willaert, MD
About this study
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.
Read more
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.
Read the detailed description
Treatment of LPP remains a challenge due to limited evidence-based guidelines and a lack of randomized controlled trials, leading to the absence of standardized therapeutic protocols and outcome measures. Currently, the treatment goal for LPP primarily focuses on halting disease progression to minimize further hair loss and alleviate associated symptoms. Treatment options for LPP include topical/intralesional corticosteroids, and systemic therapies such as hydroxychloroquine (HCQ), methotrexate (MTX), and other immunosuppressive agents. However, the absence of daily practice studies makes it challenging to establish therapeutic recommendations.
This patient preferred trial aims to fill a crucial knowledge gap in LPP management. Existing evidence lacks comprehensive guidelines for treating LPP effectively, leaving current approaches largely empirical. Aligning with the urgent need for answers highlighted by the 'Nederlandse Vereniging voor Dermatologie en Venereologie Kennisagenda Dermatologie 2019': 'Q9 - Wat is de effectiviteit van systemische behandeling bij patiënten met cicatriciële alopeciëen?' (What is the most effective systemic treatment for cicatricial alopecias) (13) underscores the pressing concern regarding the effectiveness of systemic therapy in cicatricial alopecia. This study seeks to contribute novel insights to the field by comparing the effectiveness of the two most commonly used systemic treatments, HCQ and MTX in treating LPP. By comparing the effectiveness and safety profiles of these systemics, this study endeavours to provide valuable information that can guide evidence-based treatment decisions and enhance the overall understanding of LPP management.
Objective(s)
The main objective is to assess the effectiveness in routine clinical care of hydroxychloroquine (HCQ) and methotrexate (MTX) in the treatment of adults diagnosed with lichen planopilaris (LPP) by evaluating the impact on the Lichen Planopilaris Activity Index (LPPAI) after a 6-month treatment period.
Primary objective:
To investigate the difference in LPPAI between baseline and 24 weeks of treatment between the HCQ and MTX group
Secondary objectives:
- To compare LPPAI between HCQ and MTX at 0, 12, 24, 36, and 48 weeks.
- To compare the quality of life between HCQ and MTX at 0, 12, 24, 36, and 48 weeks.
- To compare the side effects of HCQ and MTX.
- To compare the proportion of patients who discontinued therapy due to sides effects in both groups.
Skindex-29
The Skindex-29 is a dermatology-specific questionnaire. It evaluates the effect of skin conditions on physical, psychological, and social aspects. It assesses the extent to which a skin condition has influenced quality of life over the past week. The 29 questions are divided into 3 domains: symptoms, emotions, and functioning. A higher score corresponds to a greater impact on quality of life.
Other disease- and treatment-related characteristics will be retrieved from the electronic patient records.
- Conditions
- Lichen Planopilaris, Cicatricial Alopecia
- Being tested
- Hydroxychloroquine, Methotrexate
- Keywords
- Lichen planopilaris, Cicatricial alopecia, Hydroxychloroquine, Methotrexate
- Medical subject headings
- Lichen Planus, Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCQ (15) is administered orally at a dosage of 400 mg daily.
MethotrexateDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Hydroxychloroquine (HCQ) | HCQ is administered orally at a dosage of 400 mg daily. Receives: 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. Receives: Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
LPPAI
The main study parameter is the change in Lichen PlanoPilaris Activity Index (LPPAI) measured at 6 months (0-10).
Measured: at 24 weeks
Secondary outcomes (3)
LPPAI
The main study parameter is the change in Lichen PlanoPilaris Activity Index (LPPAI) measured (0-10).
Measured: at 0, 12, 36, 48 weeks
Skindex-29
Quality of Life
Measured: at 0, 12, 24, 36, 48 weeks
Side effects
Number of side effects
Measured: at 0, 12, 24, 36, 48 weeks
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 start1 Jul 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lichen PlanopilarisStudies 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
- Prospective
- Enrolment
- 56 participants (estimated)
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
- NCT06512753
- Sponsor's protocol ID
- 11940
- Acronym
- HEMLET
- 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
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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
- The Effectiveness of Hydroxychloroquine Versus Methotrexate in the Treatment of Lichen Planopilaris in Routine Clinical Care: a Patient Preference Trial
- ClinicalTrials.gov ID
- NCT06512753
- Acronym / sponsor ID
- HEMLET / 11940
- Conditions
- Lichen Planopilaris, Cicatricial Alopecia
- Keywords
- Lichen planopilaris, Cicatricial alopecia, Hydroxychloroquine, Methotrexate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- 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.
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.
Detailed description
Treatment of LPP remains a challenge due to limited evidence-based guidelines and a lack of randomized controlled trials, leading to the absence of standardized therapeutic protocols and outcome measures. Currently, the treatment goal for LPP primarily focuses on halting disease progression to minimize further hair loss and alleviate associated symptoms. Treatment options for LPP include topical/intralesional corticosteroids, and systemic therapies such as hydroxychloroquine (HCQ), methotrexate (MTX), and other immunosuppressive agents. However, the absence of daily practice studies makes it challenging to establish therapeutic recommendations.
This patient preferred trial aims to fill a crucial knowledge gap in LPP management. Existing evidence lacks comprehensive guidelines for treating LPP effectively, leaving current approaches largely empirical. Aligning with the urgent need for answers highlighted by the 'Nederlandse Vereniging voor Dermatologie en Venereologie Kennisagenda Dermatologie 2019': 'Q9 - Wat is de effectiviteit van systemische behandeling bij patiënten met cicatriciële alopeciëen?' (What is the most effective systemic treatment for cicatricial alopecias) (13) underscores the pressing concern regarding the effectiveness of systemic therapy in cicatricial alopecia. This study seeks to contribute novel insights to the field by comparing the effectiveness of the two most commonly used systemic treatments, HCQ and MTX in treating LPP. By comparing the effectiveness and safety profiles of these systemics, this study endeavours to provide valuable information that can guide evidence-based treatment decisions and enhance the overall understanding of LPP management.
Objective(s)
The main objective is to assess the effectiveness in routine clinical care of hydroxychloroquine (HCQ) and methotrexate (MTX) in the treatment of adults diagnosed with lichen planopilaris (LPP) by evaluating the impact on the Lichen Planopilaris Activity Index (LPPAI) after a 6-month treatment period.
Primary objective:
To investigate the difference in LPPAI between baseline and 24 weeks of treatment between the HCQ and MTX group
Secondary objectives:
- To compare LPPAI between HCQ and MTX at 0, 12, 24, 36, and 48 weeks.
- To compare the quality of life between HCQ and MTX at 0, 12, 24, 36, and 48 weeks.
- To compare the side effects of HCQ and MTX.
- To compare the proportion of patients who discontinued therapy due to sides effects in both groups.
Skindex-29
The Skindex-29 is a dermatology-specific questionnaire. It evaluates the effect of skin conditions on physical, psychological, and social aspects. It assesses the extent to which a skin condition has influenced quality of life over the past week. The 29 questions are divided into 3 domains: symptoms, emotions, and functioning. A higher score corresponds to a greater impact on quality of life.
Other disease- and treatment-related characteristics will be retrieved from the electronic patient records.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hydroxychloroquine (HCQ) | – | Drug: HydroxychloroquineHCQ is administered orally at a dosage of 400 mg daily. |
| Methotrexate (MTX) | – | Drug: MethotrexateMTX 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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
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 |
|---|---|---|
| HydroxychloroquineHCQ (15) is administered orally at a dosage of 400 mg daily. | Drug | Hydroxychloroquine (HCQ) |
| MethotrexateMTX (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. | Drug | Methotrexate (MTX) |
Primary outcome
LPPAI
Time frame: at 24 weeks
The main study parameter is the change in Lichen PlanoPilaris Activity Index (LPPAI) measured at 6 months (0-10).
3 secondary outcomes
LPPAI
Time frame: at 0, 12, 36, 48 weeks
Skindex-29
Time frame: at 0, 12, 24, 36, 48 weeks
Side effects
Time frame: at 0, 12, 24, 36, 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Individual participant dataSharing planned: Undecided. 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 Lichen Planopilaris and Cicatricial Alopecia, 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 4 inclusion and 16 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: status not confirmed, 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mathias Willaert, MD ((010) 704 01 10, HEMLET@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LPPAI (time frame: at 24 weeks). 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.