Study of the Characteristics of Pruritus in Patients With Frontal Fibrosing Alopecia or Lichen Planus Pilaris (PRURIT-ALOPECI)

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...)

Study Overview

• Status: Terminated
• Conditions: Alopecia; Lichen Planus
• Intervention / Treatment: Other: questionnaire

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

• Study Contact: Name: Claire ABASQ, Dr; Phone Number: +33 0298223315; Email: claire.abasq@chu-brest.fr
• Study Contact Backup: Name: Ambre FOLLIAT; Phone Number: +33 0298223315; Email: ambre.folliat@chu-brest.fr

Study Locations

• France
  • Brest, France, 29200
    • CHU Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patient; patients answer the same questionnaire whether they have frontal alopecia or lichen planus pilaris	Other: questionnaire; patients are asked to complete a questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study the relationship between disease activity (AFF or LPP) and pruritus, as well as the impact of pruritus on patients' quality of life.	ItchyQol (Itchy 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.	Questionnaire of FFASI	Hour1
Study the relationship between disease activity (AFF or LPP) and pruritus, as well as the impact of pruritus on patients' quality of life.	Questionnaire of LPPAI	Hour1

Collaborators and Investigators

• Sponsor: University Hospital, Brest

Study record dates

Study Major Dates

• Study Start (Actual): March 14, 2023
• Primary Completion (Actual): May 25, 2023
• Study Completion (Actual): May 25, 2023

Study Registration Dates

• First Submitted: February 1, 2023
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Actual): March 9, 2023

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 18, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Skin Diseases, Papulosquamous; Skin Manifestations; Hypotrichosis; Hair Diseases; Lichenoid Eruptions; Pruritus; Alopecia; Alopecia Areata; Lichen Planus
• Other Study ID Numbers: 29BRC22.0227

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available beginning three years and ending fifteen years following the final study report completion
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No