AlopeciaRDACCQVNCT04246957
Quality of Life Comparison in Patients With Different Types of Alopecia
An observational study of Alopecia and Quality of Life, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Hair loss is a frequent cause of patient consultation in dermatology. It is known to have a strong impact on patients' quality of life for many reasons; such as esthetic aspect, financial implications, social consequences. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alopecia, Quality of Life
- What is being tested?
- general quality of life questionary and specific quality of life questionary
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 4 Mar 2019to 16 Nov 2020
- 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: Every patient consulting in the dermatology department of Amiens' University Hospital for a primary alopecia will have to fill out 2 questionnaires of quality of life: one general (DLQI : Dermatology Life Quality Index) and one specific (Hair Specific Skindex 29). Every patient partner will have to complete one questionnaire of quality of life: FDLQI (Family DLQI).
Who may be able to join
- patients affiliated to social security
- patients able to understand and fill out a questionnaire
- patients over 18 years old
- patient consulting in the dermatology department of Amiens University Hospital for a primary alopecia
Who cannot join
- minors
- patients under guardianship, deprived of liberty
- scalp affections other than alopecia
- secondary alopecia
Trial locations and contacts
1 site in 1 country.
About this study
Hair loss is a frequent cause of patient consultation in dermatology. It is known to have a strong impact on patients' quality of life for many reasons; such as esthetic aspect, financial implications, social consequences. Numerous studies have assessed the impact of some types of alopecia on patients' quality of life. One study compared the quality of life in patients with scarring alopecia with patients of non-scarring alopecia. No studies have compared quality of life between the different types of scarring alopecia nor different types of non-scarring alopecia. However, none have assessed the impact on the patient partner quality of life. In addition, few treatments for alopecia are covered by national health insurance in France. The main objective is to compare the impact on the quality of life in different types of alopecia. By using the average scores of the questionnaire Dermatology Life Quality Index (DLQI) for each type of alopecia.
- Conditions
- Alopecia, Quality of Life
- Being tested
- general quality of life questionary, specific quality of life questionary
- Keywords
- alopecia, quality of life, partner
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
general quality of life questionaryBehavioural
Every patient will have to fill out a general quality of life questionary : DLQI (Dermatology Life Quality Index)
specific quality of life questionaryBehavioural
Every patient will have to fill out a specific quality of life questionary : Hair Specific Skindex 29.
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of score of questionnaire Dermatology Life Quality Index (DLQI) according alopecia type in patient life
The Dermatology life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. It is designed for people aged 16 years and above. There are 10 questions, covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, treatment. Each question refers to the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range form 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).
Measured: at day 0
Secondary outcomes (1)
Variation of score of questionnaire Dermatology Life Quality Index (DLQI) according alopecia type in spouse life
The Dermatology life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. It is designed for people aged 16 years and above. There are 10 questions, covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, treatment. Each question refers to the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range form 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).
Measured: at day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2020
- Study start4 Mar 2019
- Primary completion16 Nov 2020
- Study completion16 Nov 2020
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 Centre Hospitalier Universitaire, AmiensThe 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine LOK, Pr, Principal investigator, CHU AmiensThomas Baltazard, MD, Principal investigator, CHU AmiensNesrine Zitouni, MD, Principal investigator, CHU AmiensFanny Dessirier, MD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04246957
- Sponsor's protocol ID
- PI2019_843_0001
- Acronym
- RDACCQV
- Status last verified
- Dec 2020
- First submitted
- 21 Jan 2020
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Comparison in Patients With Different Types of Alopecia
- ClinicalTrials.gov ID
- NCT04246957
- Acronym / sponsor ID
- RDACCQV / PI2019_843_0001
- Conditions
- Alopecia, Quality of Life
- Keywords
- alopecia, quality of life, partner
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 16 Nov 2020 (actual)
- Study completion
- 16 Nov 2020 (actual)
- First posted
- 29 Jan 2020 (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.
Hair loss is a frequent cause of patient consultation in dermatology. It is known to have a strong impact on patients' quality of life for many reasons; such as esthetic aspect, financial implications, social consequences. Numerous studies have assessed the impact of some types of alopecia on patients' quality of life. One study compared the quality of life in patients with scarring alopecia with patients of non-scarring alopecia. No studies have compared quality of life between the different types of scarring alopecia nor different types of non-scarring alopecia. However, none have assessed the impact on the patient partner quality of life. In addition, few treatments for alopecia are covered by national health insurance in France. The main objective is to compare the impact on the quality of life in different types of alopecia. By using the average scores of the questionnaire Dermatology Life Quality Index (DLQI) for each type of alopecia.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every patient consulting in the dermatology department of Amiens' University Hospital for a primary alopecia will have to fill out 2 questionnaires of quality of life: one general (DLQI : Dermatology Life Quality Index) and one specific (Hair Specific Skindex 29). Every patient partner will have to complete one questionnaire of quality of life: FDLQI (Family DLQI).
Key inclusion criteria (4 listed)
- patients affiliated to social security
- patients able to understand and fill out a questionnaire
- patients over 18 years old
- patient consulting in the dermatology department of Amiens University Hospital for a primary alopecia
Key exclusion criteria (4 listed)
- minors
- patients under guardianship, deprived of liberty
- scalp affections other than alopecia
- secondary alopecia
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 |
|---|---|---|
| general quality of life questionaryEvery patient will have to fill out a general quality of life questionary : DLQI (Dermatology Life Quality Index) | Behavioural | – |
| specific quality of life questionaryEvery patient will have to fill out a specific quality of life questionary : Hair Specific Skindex 29. | Behavioural | – |
Primary outcome
Variation of score of questionnaire Dermatology Life Quality Index (DLQI) according alopecia type in patient life
Time frame: at day 0
The Dermatology life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. It is designed for people aged 16 years and above. There are 10 questions, covering the following topics: symptoms, embarrassment, shopping and home care, clothes, social and leisure, sport, work or study, close relationships, sex, treatment. Each question refers to the impact of the skin disease on the patient's life over the previous week. Each question is scored from 0 to 3, giving a possible score range form 0 (meaning no impact of skin disease on quality of life) to 30 (meaning maximum impact on quality of life).
1 secondary outcome
Variation of score of questionnaire Dermatology Life Quality Index (DLQI) according alopecia type in spouse life
Time frame: at day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- Individual participant dataSharing planned: No
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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.
Catherine LOK, Pr principal investigator
CHU Amiens
Thomas Baltazard, MD principal investigator
CHU Amiens
Nesrine Zitouni, MD principal investigator
CHU Amiens
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 Quality of Life, run by Centre Hospitalier Universitaire, Amiens 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 4 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: finished, as of the sponsor's last update on 2 Dec 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Variation of score of questionnaire Dermatology Life Quality Index (DLQI) according alopecia type in patient life (time frame: at day 0). 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 2 Dec 2020.