Alopecia AreataNCT05098600
The Epidemiology, Management and Comorbidities in Alopecia Areata in Czech Republic
An observational study of Alopecia Areata and Alopecia Totalis, run by Faculty Hospital Kralovske Vinohrady at 1 site in Czechia.
Trial summary
The study series consists of three studies with the aim to assess the incidence, prevalence, risk factors, comorbidities and management of patients with alopecia areata in Czech Republic based on the patients and registry of a dermatology clinic of a metropolitan hospital. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alopecia Areata, Alopecia Totalis, Alopecia Universalis
- What is being tested?
- Exposure of interest
- How many people
- 123 participants
- Where
- 1 siteCzechia
- Study dates
- 15 Oct 2021to 20 Dec 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult and children patients with a dermatologic condition between 1/1/2011-31/12/2020 and for the second study, adults and children with first-onset/relapsing/persistent-untreated alopecia areata visiting our clinic between 15/10/2021 and 14/10/2022 who sign informed consent are eligible.
Who may be able to join
- All patients visiting our clinic with a dermatologic condition between 1/1/2011-31/12/2020
- For the second study, only patients with histologic/dermatoscopic diagnosis of new-onset/relapsing/peristent-untreated alopecia areata, presenting to our clinic between 15/10/2021-14/10/2022 are included.
Who cannot join
- For the second study patients with other alopecias, patients denying data sharing despite signing the informed concent and presenting outside the study period are excluded.
- For the third study, patients with other types of alopecia, as well as those who signed the informed consent but refused to share their data or undergo blood tests at our hospital, and those who did not visit our outpatient department at least once a month for the required duration, were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Epidemiology, Management and Associated Conditions in Alopecia Areata in Czech Republic: A University-clinic-based Cross-sectional and Cohort Study
The study series consists of three studies with the aim to assess the incidence, prevalence, risk factors, comorbidities and management of patients with alopecia areata in Czech Republic based on the patients and registry of a dermatology clinic of a metropolitan hospital.
Read the detailed description
The first study will aim to identify the incidence and prevalence of alopecia areata in the dermatology clinic of a metropolitan teaching hospital between 1/1/2011 and 31/12/2020
The second study will assess (1) the epidemiology of autoimmune and atopic diseases in patients with alopecia areata, (2) the presence of possible risk factors responsible for the onset/relapse/exacerbation of alopecia areata, (3) the levels of vitamin D and various autoantibodies,particularly thyroid autoantibodies and (4) the variety, duration, efficacy and safety profile of treatment modalities used in our hospital for the management of alopecia areata from 15/10/2021 to 14/10/2022.
The third study will monitor the monthly oscillations of vitamin D and thyroid-autoantibodies of patients with new-onset/relasping or exacerbating alopecia areata for six months, between 15/10/2021-14/10/2022 in order to observe if changes in levels of vitamin D and thyroid-antiantibodies are associated with severity and prognosis (worsening or improvement) of alopecia areata
- Conditions
- Alopecia Areata, Alopecia Totalis, Alopecia Universalis, Alopecia Areata (& Ophiasis), Alopecia Barbae, Alopecia Diffuse
- Being tested
- Exposure of interest
- Medical subject headings
- Alopecia Areata, Alopecia universalis, Diffuse alopecia, Autoimmune Diseases, Graves Disease, Hypothyroidism, Autoimmune, Diabetes Mellitus, Type 1, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure of interestOther
Common autoimmune and atopic conditions consist of atopic dermatitis, allergic rhinitis, asthma, Crohn's disease, ulcerative colitis, Celiac disease, Pernicious anaemia, Type 1 diabetes, Autoimmune thyroiditis (Hashimoto's thyroiditis, Grave's disease, atrophic, unspecified), rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, polymyalgia rheumatica, Systemic lupus erythematosus, Sjogren syndrome, psoriasis, vitiligo, Multiple sclerosis
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients with a confirmed histologic/dermatoscopic diagnosis of Alopecia areata within the study period will be included for analysis. Receives: Other: Exposure of interest |
What is being measured
The primary outcome is the main question the study is designed to answer.
The epidemiology of Alopecia areata
The incidence and point prevalence of Alopecia areata within the study cohort during the study period, stratified by age-group and gender
Measured: 1/1/2011-31/12/2020
The epidemiology of Alopecia areata
The incidence and point prevalence of Alopecia areata (totalis, universalis, ophiasis, sisaipho, reticularis, diffuse, barbae) within the study cohort during the study period, stratified by age-group and gender
Measured: 1/10/2020-30/9/2021
Prevalence of atopic and autoimmune conditions in patients with Alopecia Areata
Prevalence of atopic and autoimmune conditions in patients with Alopecia Areata
Measured: 15/10/2021-14/10/2022
Treatments for alopecia areata
Assessment of various treatment modalities used for alopecia areata
Measured: 15/10/2021-14/10/2022
Safety and efficacy of treatments in alopecia areata
Assessment of various treatment modalities used for alopecia areata, efficacy, duration of treatment, reported side-effects and relapse rate after withdrawal
Measured: 15/10/2021-14/10/2022
Measurement of Thyroid stimulating hormone (TSH)
Measurement of TSH on first visit and once a month for 6 months. Normal values for adults 0.550-4.780 mu/l according to our laboratory. All blood tests will be performed in our laboratory at the day of the visit before any clinical examination
Measured: 15/10/2021-14/10/2022
Measurement of free Thyroxine (fT4)
Measurement of fT4 on first visit and once a month for 6 months. Normal values for adults 11.50-22.70 pmol/l according to our laboratory. All blood tests will be performed in our laboratory at the day of the visit before any clinical examination
Measured: 15/10/2021-14/10/2022
Measurement of free Triodothyronine (fT3)
Measurement of fT3 on first visit and once a month for 6 months. Normal values for adults 3.50-6.50 pmol/l according to our laboratory. All blood tests will be performed in our laboratory at the day of the visit before any clinical examination
Measured: 15/10/2021-14/10/2022
Measurement of Thyroid peroxidase autoantibodies (TPOAbs)
Measurement of TPOAbs on first visit and once a month for 6 months. Normal values for adults <60 kU/l according to our laboratorypmol/l. All blood tests will be performed in our laboratory at the day of the visit before any clinical examination
Measured: 15/10/2021-14/10/2022
Measurement of thyreoglobulin autoantibodies (TgAbs)
Measurement of TgAbs on first visit and once a month for 6 months. Normal values for adults <4.5 kIUl/l according to our laboratory. All blood tests will be performed in our laboratory at the day of the visit before any clinical examination
Measured: 15/10/2021-14/10/2022
Measurement of anti TSH receptor antibodies (TRAbs)
Measurement of TRAbs on first visit and once a month for 6 months. Normal values for adults <1.22 Ul/l according to our laboratory. All blood tests will be performed in our laboratory at the day of the visit before any clinical examination
Measured: 15/10/2021-14/10/2022
Measurement of Vitamin D levels
Measurement of Vitamin D levels on first visit and once a month for 6 months. Normal values for adults are 75.0-250.0 nmol/l acording to our laboratory. All blood tests will be performed in our laboratory at the day of the visit before any clinical examination
Measured: 15/10/2021-14/10/2022
Secondary outcomes (2)
Prevalence of atopic and autoimmune conditions in the family history of patients with Alopecia Areata
Prevalence of atopic and autoimmune conditions in parents and siblings of patients with Alopecia Areata
Measured: 15/10/2021-14/10/2022
Identification and prevalence of possible exacerbating factors in patients with Alopecia Areata
Identification of possible risk factors occuring within 6 months from the onset/relapse/worsening of alopecia areata, according to patient history
Measured: 15/10/2021-14/10/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start15 Oct 2021
- Primary completion14 Oct 2022
- Study completion20 Dec 2022
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.
- 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
- Prospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty Hospital Kralovske Vinohrady
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Athanasios J. Stefanis, Faculty Hospital Kralovske Vinohrady
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05098600
- Sponsor's protocol ID
- NKS1001
- Status last verified
- Nov 2024
- First submitted
- 16 Oct 2021
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Epidemiology, Management and Associated Conditions in Alopecia Areata in Czech Republic: A University-clinic-based Cross-sectional and Cohort Study
- ClinicalTrials.gov ID
- NCT05098600
- Acronym / sponsor ID
- NKS1001
- Conditions
- Alopecia Areata, Alopecia Totalis, Alopecia Universalis, Alopecia Areata (& Ophiasis), Alopecia Barbae, Alopecia Diffuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Faculty Hospital Kralovske VinohradyOther government
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 14 Oct 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 28 Oct 2021 (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 study series consists of three studies with the aim to assess the incidence, prevalence, risk factors, comorbidities and management of patients with alopecia areata in Czech Republic based on the patients and registry of a dermatology clinic of a metropolitan hospital.
Detailed description
The first study will aim to identify the incidence and prevalence of alopecia areata in the dermatology clinic of a metropolitan teaching hospital between 1/1/2011 and 31/12/2020
The second study will assess (1) the epidemiology of autoimmune and atopic diseases in patients with alopecia areata, (2) the presence of possible risk factors responsible for the onset/relapse/exacerbation of alopecia areata, (3) the levels of vitamin D and various autoantibodies,particularly thyroid autoantibodies and (4) the variety, duration, efficacy and safety profile of treatment modalities used in our hospital for the management of alopecia areata from 15/10/2021 to 14/10/2022.
The third study will monitor the monthly oscillations of vitamin D and thyroid-autoantibodies of patients with new-onset/relasping or exacerbating alopecia areata for six months, between 15/10/2021-14/10/2022 in order to observe if changes in levels of vitamin D and thyroid-antiantibodies are associated with severity and prognosis (worsening or improvement) of alopecia areata
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: Exposure of interestPatients with a confirmed histologic/dermatoscopic diagnosis of Alopecia areata within the study period will be included for analysis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult and children patients with a dermatologic condition between 1/1/2011-31/12/2020 and for the second study, adults and children with first-onset/relapsing/persistent-untreated alopecia areata visiting our clinic between 15/10/2021 and 14/10/2022 who sign informed consent are eligible.
Key inclusion criteria (2 listed)
- All patients visiting our clinic with a dermatologic condition between 1/1/2011-31/12/2020
- For the second study, only patients with histologic/dermatoscopic diagnosis of new-onset/relapsing/peristent-untreated alopecia areata, presenting to our clinic between 15/10/2021-14/10/2022 are included.
Key exclusion criteria (2 listed)
- For the second study patients with other alopecias, patients denying data sharing despite signing the informed concent and presenting outside the study period are excluded.
- For the third study, patients with other types of alopecia, as well as those who signed the informed consent but refused to share their data or undergo blood tests at our hospital, and those who did not visit our outpatient department at least once a month for the required duration, were excluded.
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 |
|---|---|---|
| Exposure of interestCommon autoimmune and atopic conditions consist of atopic dermatitis, allergic rhinitis, asthma, Crohn's disease, ulcerative colitis, Celiac disease, Pernicious anaemia, Type 1 diabetes, Autoimmune thyroiditis (Hashimoto's thyroiditis, Grave's disease, atrophic, unspecified), rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, polymyalgia rheumatica, Systemic lupus erythematosus, Sjogren syndrome, psoriasis, vitiligo, Multiple sclerosis | Other | Cases |
Primary outcome
The epidemiology of Alopecia areata
Time frame: 1/1/2011-31/12/2020
The incidence and point prevalence of Alopecia areata within the study cohort during the study period, stratified by age-group and gender
The epidemiology of Alopecia areata
Time frame: 1/10/2020-30/9/2021
The incidence and point prevalence of Alopecia areata (totalis, universalis, ophiasis, sisaipho, reticularis, diffuse, barbae) within the study cohort during the study period, stratified by age-group and gender
Prevalence of atopic and autoimmune conditions in patients with Alopecia Areata
Time frame: 15/10/2021-14/10/2022
Prevalence of atopic and autoimmune conditions in patients with Alopecia Areata
Treatments for alopecia areata
Time frame: 15/10/2021-14/10/2022
Assessment of various treatment modalities used for alopecia areata
Safety and efficacy of treatments in alopecia areata
Time frame: 15/10/2021-14/10/2022
Assessment of various treatment modalities used for alopecia areata, efficacy, duration of treatment, reported side-effects and relapse rate after withdrawal
Measurement of Thyroid stimulating hormone (TSH)
Time frame: 15/10/2021-14/10/2022
Measurement of TSH on first visit and once a month for 6 months. Normal values for adults 0.550-4.780 mu/l according to our laboratory. All blood tests will be performed in our laboratory at the day of the visit before any clinical examination
Measurement of free Thyroxine (fT4)
Time frame: 15/10/2021-14/10/2022
Measurement of fT4 on first visit and once a month for 6 months. Normal values for adults 11.50-22.70 pmol/l according to our laboratory. All blood tests will be performed in our laboratory at the day of the visit before any clinical examination
Measurement of free Triodothyronine (fT3)
Time frame: 15/10/2021-14/10/2022
Measurement of fT3 on first visit and once a month for 6 months. Normal values for adults 3.50-6.50 pmol/l according to our laboratory. All blood tests will be performed in our laboratory at the day of the visit before any clinical examination
Measurement of Thyroid peroxidase autoantibodies (TPOAbs)
Time frame: 15/10/2021-14/10/2022
Measurement of TPOAbs on first visit and once a month for 6 months. Normal values for adults <60 kU/l according to our laboratorypmol/l. All blood tests will be performed in our laboratory at the day of the visit before any clinical examination
Measurement of thyreoglobulin autoantibodies (TgAbs)
Time frame: 15/10/2021-14/10/2022
Measurement of TgAbs on first visit and once a month for 6 months. Normal values for adults <4.5 kIUl/l according to our laboratory. All blood tests will be performed in our laboratory at the day of the visit before any clinical examination
Measurement of anti TSH receptor antibodies (TRAbs)
Time frame: 15/10/2021-14/10/2022
Measurement of TRAbs on first visit and once a month for 6 months. Normal values for adults <1.22 Ul/l according to our laboratory. All blood tests will be performed in our laboratory at the day of the visit before any clinical examination
Measurement of Vitamin D levels
Time frame: 15/10/2021-14/10/2022
Measurement of Vitamin D levels on first visit and once a month for 6 months. Normal values for adults are 75.0-250.0 nmol/l acording to our laboratory. All blood tests will be performed in our laboratory at the day of the visit before any clinical examination
2 secondary outcomes
Prevalence of atopic and autoimmune conditions in the family history of patients with Alopecia Areata
Time frame: 15/10/2021-14/10/2022
Identification and prevalence of possible exacerbating factors in patients with Alopecia Areata
Time frame: 15/10/2021-14/10/2022
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 3 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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 Areata and Alopecia Totalis, run by Faculty Hospital Kralovske Vinohrady at 1 site in Czechia.
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 2 inclusion and 2 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 3 Dec 2024. 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 Czechia. 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?
The epidemiology of Alopecia areata (time frame: 1/1/2011-31/12/2020). The study lists 12 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 3 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.