AzTrials
AzTrials

Alopecia AreataPelBurdNCT05588310

Quantification of the Socio-economic Multifacet Burden of Alopecia Areata and Identification of the Associated Factors

An observational study of Alopecia Areata, run by University Hospital, Toulouse at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Alopecia areata (AA) is a complex autoimmune disorder with an estimated lifetime risk of 1.7% where both genetic pre-disposition and environmental factors contribute. It typically presents with sharply demarcated round patches of non-scarring hair loss that may present at any age. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alopecia Areata
How many people
150 participants
Where
1 siteFrance
Study dates
8 Nov 2022to Apr 2025
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: Patients whom suffer from Alopecia Areata

Who may be able to join

  • Adult patients (> 18 years).
  • Alopecia Areata whose diagnosis has been confirmed by a dermatologist according to the standardized diagnostic criteria.
  • < 2 years duration of current episode of scalp hair loss.
  • Severity > S2 (> 25% hair loss) as assessed by the Alopecia Tool (SALT).

Who cannot join

  • Patients under juridical protection.
  • Patients not covered by social security.
  • Patients unable to understand French

Trial locations and contacts

1 site in 1 country.

France1 site, 1 recruiting
  • Toulouse University hospital

    Toulouse, 31300

    Juliette MAZEREEUW-HAUTIER, Pr, 05 67 77 81 26 ext. +33, mazereeuw-hautier.j@chu-toulouse.fr

    Hélène TEXIER, 05 67 77 81 80 ext. +33, texier.h@chu-toulouse.fr

    Recruiting

Other trials in France

About this study

Alopecia areata (AA) is a complex autoimmune disorder with an estimated lifetime risk of 1.7% where both genetic pre-disposition and environmental factors contribute. It typically presents with sharply demarcated round patches of non-scarring hair loss that may present at any age. Many patients with AA are dissatisfied with current medical treatments and use alternative therapies and cosmetics. This study will generate new data on the current situation of psychosocial and financial burden of AA. It will help to identify unmet needs and to understand the disease issues. It will also be the basis for the planification of future supporting measures.

Read the detailed description

Alopecia areata (AA) is a complex autoimmune disorder with an estimated lifetime risk of 1.7% where both genetic pre-disposition and environmental factors contribute. It typically presents with sharply demarcated round patches of non-scarring hair loss that may present at any age. Current medical therapies (topical or systemic) for AA are not reliably effective, particularly for severe disease and there is no robust evidence from high-quality randomized controlled trials. Patients with AA experience significant mental health and health related quality of life (HRQoL) impairment. Furthermore, at the country level, skin conditions such as AA ranged from 2nd to 11th leading cause of years lived with disability. It was shown that AA appears to affect all countries across the world similarly, and the health burden has remained stable despite substantial advances in healthcare and health-related resources. More recently, Mesinkovska et al demonstrated that the impact of AA extends beyond cosmetic concerns and carries a considerable psychosocial burden.

Many patients with AA are dissatisfied with current medical treatments and use alternative therapies and cosmetics. Cosmetics and not reimbursed treatments can weigh heavily on patients spending.This study will generate new data on the current situation of psychosocial and financial burden of AA. It will help to identify unmet needs and to understand the disease issues. It will also be the basis for the planification of future supporting measures.

Conditions
Alopecia Areata
Keywords
Socio-economic burden, alopecia areata, out-of-pocket expenditures
Medical subject headings
Alopecia Areata

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Calculate the Out Of Pocket (OOP) expenditures of patients whom suffer from alopecia areata

    To describe the OOP expenditures related to Alopecia Areata from a patient point of view by using the retrospective questionnaire during 6 months and using the prospective weekly follow-up patient diary during 6 months.

    Measured: 12 months

Secondary outcomes (8)
  1. Calculate direct medical costs and indirect costs limited to work stopping and working reduction time related to Alopecia Areata

    To describe direct medical costs, hospitalizations stays, visits and additional tests will be collected using patients diary and interviews. These data will be completed by PMSI (Programme de Médicalisation des Systèmes d'Information) data of each participating hospital. Indirect costs will be limited to work stopping or working reduction time and will be collected by self reporting PelBurd Version n°2.0 of April 8, 2022 10 in patients diaries. Socio-professional category and job will be collected during the first visit in order to assess costs related job changes. These costs will be established over a period of one year on retrospective (interview) and prospective (diary) basis.

    Measured: 12 months

  2. Evaluate the impact of Alopecia Areata on Health Related Quality of Life (HRQoL) - DLQI

    Health Realted Quality of Life will be assessed using the validated French versions of the dermatology specific questionnaire " Dermatology Life Quality Index " (DLQI). The questionnaire will be self-evaluated by patients at M0 and M6. DLQI consists of 10 questions with 4 points likert answers and ranges from 0 (no effect on QoL) to 30 maximum effect on QoL. DLQI scores can also be categorised into 5 different levels (very much, a lot, a little, not at all, not relevant) 13.

    Measured: 6 months

  3. Evaluate the impact of Alopecia Areata on Health Related Quality of Life (HRQoL) - AA-QLI

    Health Realted Quality of Life will be assessed using the validated French versions of the disease specific questionnaire for AA (AA-QLI). The questionnaire will be self-evaluated by patients at M0 and M6. AA-QLI consists of 21 questions with 4 points likert answers. It is scored by averaging 3 subscales and presented on a 0 (no effect on QoL) to 100 points scale.

    Measured: 6 months

  4. Evaluate the patient's perceived stress

    Evaluate the patient's perceived stress by using the validated French version of the Perceived stress scale (PSS) self-evaluated by patients at M0 and M6. The perceived stress scale consisted of 10 questions with 5 points likert answers. It ranges from 0 (no perceived stress) to 40 (highest possible perceived stress) and can be categorized into 3 different levels (low, moderate and high perceived stress)

    Measured: 6 months

  5. Evaluate the impact of Alopecia Areata on depression symptoms

    Evaluate the impact of Alopecia Areata on depression symptoms by using the validated French version of the Patient health questionnaire 9 (PHQ-9). This questionnaire will be self-evaluated by patients at M0 and M6. The PHQ9 questionnaire consists of 9 questions with 4 points likert answers and ranges from 0 (absence of depressive symptoms) to 27 (severe depressive symptoms). PHQ-9 scores can be categorized in 5 levels (none, mild, moderate, moderately severe, severe). Patients with a PHQ-9 score above 10 should be referred to a psychiatric evaluation.

    Measured: 6 months

  6. Evaluate the impact of Alopecia Areata on anxiety symptoms

    To evaluate the impact of AA on anxiety symptoms by using the validated French version of the General anxiety disorder 7 (GAD 7), self-evaluated by patients at M0 and M6. The GAD-7 consists of 7 questions with 4 points likert answers and ranges from 0 (absence of anxious symptoms) to 27 (severe anxious symptoms). GAD-7 scores can be categorized in 4 levels (none, mild, moderate, severe).

    Measured: 6 months

  7. Describing the care pathway for Alopecia Areata patients

    To describe the care pathway for Alopecia Areata patients (delay to diagnosis and treatment), the clinician will report during the first consultation (M0), the number of consulted physicians and the following dates: first symptoms, first appointment with a medical doctor (MD), first appointment with a dermatologist, diagnosis, beginning of the first treatment. In rare or neglected diseases diagnostic delay is usually defined as the delay between first consultation with a MD and the final diagnosis . We will also calculate the delay to consultation (defined as the time between first symptoms and first consultation with a MD), the delay to dermatologist consultation (defined as the time between first consultation with a MD and first consultation with a dermatologist) and the delay to first treatment (defined as the time between the first consultation with a MD and the first treatment).

    Measured: 6 months

  8. Describing the impact of Alopecia Areata on work productivity

    To describe the impact of AA on work productivity, we will use the validated French version of the Work Productivity and Activity Impairment (WPAI) (self-assessed by patients at M0 and M6). The WPAI is a 6 questions score that assesses hours missed at work, loss of productivity at work and in daily activities because of a specific health issue. The WPAI is expressed as 4 impairments: percent work time missed due to health, percent impairment while working due to health issue, percent overall work impairment due to health issue, percent activity impairment due to health issue

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2022
  2. Study start8 Nov 2022
  3. Primary completionApr 2025 (estimated)
  4. Study completionApr 2025 (estimated)

Resources

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
Cohort
Time perspective
Retrospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05588310
Sponsor's protocol ID
RC31/22/0054
Other IDs
2022-A00986-37
Acronym
PelBurd
Status last verified
May 2023
First submitted
10 Jun 2022
Last updated
15 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Alopecia Areata, run by University Hospital, Toulouse 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 3 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: status not confirmed, as of the sponsor's last update on 15 May 2023. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Juliette Mazereeuw-Hautier, Pr (05 67 77 81 26 ext. +33, mazereeuw-hautier.j@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Calculate the Out Of Pocket (OOP) expenditures of patients whom suffer from alopecia areata (time frame: 12 months). 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 15 May 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in