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.
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
- 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
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.
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)
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
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
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
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
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
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
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
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.
- First posted20 Oct 2022
- Study start8 Nov 2022
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alopecia AreataStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Juliette Mazereeuw-Hautier, Pr, Principal investigator, University Hospital, Toulouse
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
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of the Socio-economic Multifacet Burden of Alopecia Areata and Identification of the Associated Factors
- ClinicalTrials.gov ID
- NCT05588310
- Acronym / sponsor ID
- PelBurd / RC31/22/0054
- Conditions
- Alopecia Areata
- Keywords
- Socio-economic burden, alopecia areata, out-of-pocket expenditures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 8 Nov 2022 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 20 Oct 2022 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients whom suffer from Alopecia Areata
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- Patients under juridical protection.
- Patients not covered by social security.
- Patients unable to understand French
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Calculate the Out Of Pocket (OOP) expenditures of patients whom suffer from alopecia areata
Time frame: 12 months
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.
8 secondary outcomes
Calculate direct medical costs and indirect costs limited to work stopping and working reduction time related to Alopecia Areata
Time frame: 12 months
Evaluate the impact of Alopecia Areata on Health Related Quality of Life (HRQoL) - DLQI
Time frame: 6 months
Evaluate the impact of Alopecia Areata on Health Related Quality of Life (HRQoL) - AA-QLI
Time frame: 6 months
Evaluate the patient's perceived stress
Time frame: 6 months
Evaluate the impact of Alopecia Areata on depression symptoms
Time frame: 6 months
Evaluate the impact of Alopecia Areata on anxiety symptoms
Time frame: 6 months
Describing the care pathway for Alopecia Areata patients
Time frame: 6 months
Describing the impact of Alopecia Areata on work productivity
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2023.
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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.
Juliette Mazereeuw-Hautier, Pr principal investigator
University Hospital, Toulouse
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 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.