Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06512753
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-16
Brief Title:
The Effectiveness of Hydroxychloroquine Versus Methotrexate in the Treatment of Lichen Planopilaris in Routine Clinical Care a Patient Preference Trial
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effectiveness of Hydroxychloroquine Versus Methotrexate in the Treatment of Lichen Planopilaris in Routine Clinical Care a Patient Preference Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HEMLET
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
Objectives 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 diseases 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
Objectives 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 diseases 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 topicalintralesional 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
Objectives
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
2 To compare LPPAI between HCQ and MTX at 0 12 24 36 and 48 weeks
3 To compare the quality of life between HCQ and MTX at 0 12 24 36 and 48 weeks
4 To compare the side effects of HCQ and MTX
5 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
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
Objectives
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
2 To compare LPPAI between HCQ and MTX at 0 12 24 36 and 48 weeks
3 To compare the quality of life between HCQ and MTX at 0 12 24 36 and 48 weeks
4 To compare the side effects of HCQ and MTX
5 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None