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

• Sponsor: University Hospital, Brest (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05761158
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 8.3

Study Details

Study Description

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...)

Condition or Disease	Intervention/Treatment	Phase
Alopecia; Lichen Planus	Other: questionnaire

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Study of the Characteristics of Pruritus in Patients With Frontal Fibrosing Alopecia or Lichen Planus Pilaris
• Anticipated Study Start Date: Feb 27, 2023
• Anticipated Primary Completion Date: Feb 27, 2024
• Anticipated Study Completion Date: Feb 27, 2024

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Study of the characteristics of pruritus in patients with frontal fibrosis alopecia or lichen planus pilaris [Hour1]

   Questionnaire of Brest

2. Study of the characteristics of pruritus in patients with frontal fibrosis alopecia or lichen [Hour1]

   5D itch scale

Secondary Outcome Measures

1. Study the relationship between disease activity (AFF or LPP) and pruritus, as well as the impact of pruritus on patients' quality of life. [Hour1]

   ItchyQol (Itchy Quality of Life)

2. Study the relationship between disease activity (AFF or LPP) and pruritus, as well as the impact of pruritus on patients' quality of life. [Hour1]

   Questionnaire of FFASI

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]

   Questionnaire of LPPAI

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Brest	Brest		France	29200

Sponsors and Collaborators

• University Hospital, Brest

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Brest
• ClinicalTrials.gov Identifier: NCT05761158
• Other Study ID Numbers: 29BRC22.0227
• First Posted: Mar 9, 2023
• Last Update Posted: Mar 9, 2023
• Last Verified: Feb 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Alopecia; Alopecia Areata; Pruritus; Lichen Planus

Study Results

No Results Posted as of Mar 9, 2023