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TerminatedNCT05761158PRURIT-ALOPECIUpdated Apr 24, 2025

Study of the Characteristics of Pruritus in Patients With Frontal Fibrosing Alopecia or Lichen Planus Pilaris

An observational study in Alopecia and Lichen Planus, sponsored by University Hospital, Brest. Terminated at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-24.

Sponsored by University Hospital, Brest · Observational

Why this study was terminated
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 type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
21
Ages
18 Years and older
Sex
All
01

Study 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...)

02

Conditions studied

  • Alopecia
  • Lichen Planus
03

In context

Alopecia

511 studies on the registry are indexed under Alopecia; 128 are open to participants now.

This study's enrollment of 21 is below the median of 95 across 52 observational studies indexed under Alopecia.

Browse Alopecia studies →

Lead sponsor

University Hospital, Brest is the lead sponsor of 601 studies on the registry; 136 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
21 participants (actual)
Patient registry
No

Groups and cohorts

  • patient

    patients answer the same questionnaire whether they have frontal alopecia or lichen planus pilaris

    Other: questionnaire

Interventions

  • Otherquestionnaire

    patients are asked to complete a questionnaire

06

What researchers measure

Primary outcomes

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

    Questionnaire of Brest

    Time frame: Hour1

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

    5D itch scale

    Time frame: Hour1

Secondary outcomes

  1. 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)

    Time frame: Hour1

  2. 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

    Time frame: Hour1

  3. 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

    Time frame: Hour1

07

Study locations

1 site
  • CHU Brest
    Brest, 29200, France
08

References and documents

Individual participant data

Plan to share: Yes — All collected data that underlie results in a publication

Supporting information: 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05761158
Responsible party
Sponsor
First posted
Mar 9, 2023
Start date
Mar 14, 2023
Primary completion
May 25, 2023
Completion
May 25, 2023
Last update
Apr 24, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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