AlopeciaPRURIT-ALOPECINCT05761158
Study of the Characteristics of Pruritus in Patients With Frontal Fibrosing Alopecia or Lichen Planus Pilaris
An observational study of Alopecia and Lichen Planus, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alopecia, Lichen Planus
- What is being tested?
- questionnaire
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 14 Mar 2023to 25 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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...)
- Conditions
- Alopecia, Lichen Planus
- Being tested
- questionnaire
- Medical subject headings
- Alopecia, Lichen Planus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
patients are asked to complete a questionnaire
| Study group | Role | What they receive |
|---|---|---|
| patient | patients answer the same questionnaire whether they have frontal alopecia or lichen planus pilaris Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of the characteristics of pruritus in patients with frontal fibrosis alopecia or lichen planus pilaris
Questionnaire of Brest
Measured: Hour1
Study of the characteristics of pruritus in patients with frontal fibrosis alopecia or lichen
5D itch scale
Measured: 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.
ItchyQol (Itchy Quality of Life)
Measured: 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
Measured: 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
Measured: Hour1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2023
- Study start14 Mar 2023
- Primary completion25 May 2023
- Study completion25 May 2023
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlopeciaStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05761158
- Sponsor's protocol ID
- 29BRC22.0227
- Acronym
- PRURIT-ALOPECI
- Status last verified
- Jan 2025
- First submitted
- 1 Feb 2023
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Characteristics of Pruritus in Patients With Frontal Fibrosing Alopecia or Lichen Planus Pilaris
- ClinicalTrials.gov ID
- NCT05761158
- Acronym / sponsor ID
- PRURIT-ALOPECI / 29BRC22.0227
- Conditions
- Alopecia, Lichen Planus
- Study type
- Observational
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 25 May 2023 (actual)
- First posted
- 9 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient | – | Other: questionnairepatients answer the same questionnaire whether they have frontal alopecia or lichen planus pilaris |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairepatients are asked to complete a questionnaire | Other | patient |
Primary outcome
Study of the characteristics of pruritus in patients with frontal fibrosis alopecia or lichen planus pilaris
Time frame: Hour1
Questionnaire of Brest
Study of the characteristics of pruritus in patients with frontal fibrosis alopecia or lichen
Time frame: Hour1
5D itch scale
3 secondary outcomes
Study the relationship between disease activity (AFF or LPP) and pruritus, as well as the impact of pruritus on patients' quality of life.
Time frame: Hour1
Study the relationship between disease activity (AFF or LPP) and pruritus, as well as the impact of pruritus on patients' quality of life.
Time frame: Hour1
Study the relationship between disease activity (AFF or LPP) and pruritus, as well as the impact of pruritus on patients' quality of life.
Time frame: Hour1
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alopecia and Lichen Planus, run by University Hospital, Brest at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study of the characteristics of pruritus in patients with frontal fibrosis alopecia or lichen planus pilaris (time frame: Hour1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.