Study Stopped
Discontinuation of the study was justified by the inclusion of 21/100 patients, which finally enabled a relevant analysis to be made in view of the homogeneity of the results.
Study of the Characteristics of Pruritus in Patients With Frontal Fibrosing Alopecia or Lichen Planus Pilaris
PRURIT-ALOPECI
1 other identifier
observational
21
1 country
1
Brief Summary
The prevalence of pruritus has been studied in frontal fibrosis alopecia (FFA) and lichen planus pilaris (LPP), but there are no studies evaluating the characteristics of pruritus, the correlation between pruritus and disease activity, and its impact on quality of life. The knowledge of the characteristics of pruritus, of the link "disease activity - pruritus", and its impact on the quality of life could allow us to modify the management of the patient (modification or intensification of therapy, close monitoring...)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2023
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2023
CompletedFirst Posted
Study publicly available on registry
March 9, 2023
CompletedStudy Start
First participant enrolled
March 14, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2023
CompletedApril 24, 2025
January 1, 2025
2 months
February 1, 2023
April 22, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Study of the characteristics of pruritus in patients with frontal fibrosis alopecia or lichen planus pilaris
Questionnaire of Brest
Hour1
Study of the characteristics of pruritus in patients with frontal fibrosis alopecia or lichen
5D itch scale
Hour1
Secondary Outcomes (3)
Study the relationship between disease activity (AFF or LPP) and pruritus, as well as the impact of pruritus on patients' quality of life.
Hour1
Study the relationship between disease activity (AFF or LPP) and pruritus, as well as the impact of pruritus on patients' quality of life.
Hour1
Study the relationship between disease activity (AFF or LPP) and pruritus, as well as the impact of pruritus on patients' quality of life.
Hour1
Study Arms (1)
patient
patients answer the same questionnaire whether they have frontal alopecia or lichen planus pilaris
Interventions
Eligibility Criteria
Major patients with frontal fibrosing alopecia or lichen planus pilaris, with scalp pruritus, followed in the Dermatology Department of the CHRU Brest and having given their consent to participate in the study.
You may qualify if:
- Major patient.
- Fibrosing frontal alopecia or lichen planus pilaris
- Presence of pruritus of the scalp : a positive response to the question "do you experience itchy scalp?"
- The patient received an information note and did not object to the study
You may not qualify if:
- Patients under 18 years of age.
- Other pathologies causing scalp pruritus (seborrheic dermatitis, contact dermatitis, lupus, Quinquaud's decalcifying folliculitis, ectoparasitosis, scalp psoriasis, ringworm, red sclap syndrome, dermatomyositis, central centrifugal cicatricial alopecia (CCCA))
- Refusal to participate by the patient.
- Patient under legal protection (curatorship, guardianship, ...)
- Patient not covered by social security
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Brest
Brest, 29200, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2023
First Posted
March 9, 2023
Study Start
March 14, 2023
Primary Completion
May 25, 2023
Study Completion
May 25, 2023
Last Updated
April 24, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be available beginning three years and ending fifteen years following the final study report completion
- Access Criteria
- Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
All collected data that underlie results in a publication