NCT05761158

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 9, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

March 14, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2023

Completed
Last Updated

April 24, 2025

Status Verified

January 1, 2025

Enrollment Period

2 months

First QC Date

February 1, 2023

Last Update Submit

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

Other: questionnaire

Interventions

patients are asked to complete a questionnaire

patient

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

Location

MeSH Terms

Conditions

AlopeciaLichen Planus

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsLichenoid EruptionsSkin Diseases, Papulosquamous

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

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

All collected data that underlie results in a publication

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.

Locations