Covid19NCT04834102
COVID-19 Induced Telogen Effluvium
An observational study of Covid19 and Telogen Effluvium, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial summary
This study inquires about the development of Telogen effluvium following the SARS-CoV-2 infection Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid19, Telogen Effluvium, SARS-CoV Infection
- What is being tested?
- Blood Tests
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jan 2021to 27 Apr 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults that are diagnosed with COVID-19 in the past year.
Who may be able to join
- Sars-CoV-2 infection in the past year
Who cannot join
- Other common causes of Telogen effluvium ( such as anemia, iron deficiency, thyroid dysfunction)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medeniyet University
Istanbul, Kadıköy, 34720
Umut Mert YILDIRIM, Dr., +905423383842, umutmertyildirim@gmail.com
Hasan Aksoy, Specialist Dr., +905053005460, haxoil@yahoo.com
About this study
This study inquires about the development of Telogen effluvium following the SARS-CoV-2 infection
Read the detailed description
Telogen effluvium (TE) is one of the most common causes of non-scarring alopecia. During the COVİD-19 pandemic, there is an increased number of Telogen effluvium patients.This study inquires about the development of Telogen effluvium following the SARS-CoV-2 infection and correlation between the severity of covid-19 and TE.
- Conditions
- Covid19, Telogen Effluvium, SARS-CoV Infection, Alopecia
- Being tested
- Blood Tests
- Keywords
- Telogen Effluvium, Covid-19, Alopecia
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome, Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood TestsDiagnostic test
Evaluation of blood ferritin, hemoglobine, serum iron and serum iron binding capacity
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair shedding
Physical examination of hair and scalp, trichoscopy, hair pull test
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start27 Jan 2021
- Primary completion27 Apr 2021 (estimated)
- Study completion27 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Aksoy, Istanbul Medeniyet University
- Investigators
- Hasan AKSOY, Dr., Principal investigator, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834102
- Sponsor's protocol ID
- 2021/0123
- Status last verified
- Apr 2021
- First submitted
- 4 Apr 2021
- Last updated
- 6 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Asghar F, Shamim N, Farooque U, Sheikh H, Aqeel R. Telogen Effluvium: A Review of the Literature. Cureus. 2020 May 27;12(5):e8320. doi: 10.7759/cureus.8320.
PubMed 32607303Mieczkowska K, Deutsch A, Borok J, Guzman AK, Fruchter R, Patel P, Wind O, McLellan BN, Mann RE, Halverstam CP. Telogen effluvium: a sequela of COVID-19. Int J Dermatol. 2021 Jan;60(1):122-124. doi: 10.1111/ijd.15313. Epub 2020 Nov 23. No abstract available.
PubMed 33226117Rizzetto G, Diotallevi F, Campanati A, Radi G, Bianchelli T, Molinelli E, Mazzanti S, Offidani A. Telogen effluvium related to post severe Sars-Cov-2 infection: Clinical aspects and our management experience. Dermatol Ther. 2021 Jan;34(1):e14547. doi: 10.1111/dth.14547. Epub 2020 Nov 23.
PubMed 33190397Cline A, Kazemi A, Moy J, Safai B, Marmon S. A surge in the incidence of telogen effluvium in minority predominant communities heavily impacted by COVID-19. J Am Acad Dermatol. 2021 Mar;84(3):773-775. doi: 10.1016/j.jaad.2020.11.032. Epub 2020 Dec 10. No abstract available.
PubMed 33310111
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Induced Telogen Effluvium
- ClinicalTrials.gov ID
- NCT04834102
- Acronym / sponsor ID
- 2021/0123
- Conditions
- Covid19, Telogen Effluvium, SARS-CoV Infection, Alopecia
- Keywords
- Telogen Effluvium, Covid-19, Alopecia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 27 Apr 2021 (estimated)
- Study completion
- 27 Apr 2021 (estimated)
- First posted
- 6 Apr 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.
This study inquires about the development of Telogen effluvium following the SARS-CoV-2 infection
Detailed description
Telogen effluvium (TE) is one of the most common causes of non-scarring alopecia. During the COVİD-19 pandemic, there is an increased number of Telogen effluvium patients.This study inquires about the development of Telogen effluvium following the SARS-CoV-2 infection and correlation between the severity of covid-19 and TE.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults that are diagnosed with COVID-19 in the past year.
Key inclusion criteria (1 listed)
- Sars-CoV-2 infection in the past year
Key exclusion criteria (1 listed)
- Other common causes of Telogen effluvium ( such as anemia, iron deficiency, thyroid dysfunction)
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 |
|---|---|---|
| Blood TestsEvaluation of blood ferritin, hemoglobine, serum iron and serum iron binding capacity | Diagnostic test | – |
Primary outcome
Hair shedding
Time frame: 3 months
Physical examination of hair and scalp, trichoscopy, hair pull test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Results publication: PubMed 32607303Asghar F, Shamim N, Farooque U, Sheikh H, Aqeel R. Telogen Effluvium: A Review of the Literature. Cureus. 2020 May 27;12(5):e8320. doi: 10.7759/cureus.8320.
- Results publication: PubMed 33226117Mieczkowska K, Deutsch A, Borok J, Guzman AK, Fruchter R, Patel P, Wind O, McLellan BN, Mann RE, Halverstam CP. Telogen effluvium: a sequela of COVID-19. Int J Dermatol. 2021 Jan;60(1):122-124. doi: 10.1111/ijd.15313. Epub 2020 Nov 23. No abstract available.
- Results publication: PubMed 33190397Rizzetto G, Diotallevi F, Campanati A, Radi G, Bianchelli T, Molinelli E, Mazzanti S, Offidani A. Telogen effluvium related to post severe Sars-Cov-2 infection: Clinical aspects and our management experience. Dermatol Ther. 2021 Jan;34(1):e14547. doi: 10.1111/dth.14547. Epub 2020 Nov 23.
- Results publication: PubMed 33310111Cline A, Kazemi A, Moy J, Safai B, Marmon S. A surge in the incidence of telogen effluvium in minority predominant communities heavily impacted by COVID-19. J Am Acad Dermatol. 2021 Mar;84(3):773-775. doi: 10.1016/j.jaad.2020.11.032. Epub 2020 Dec 10. No abstract available.
- 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.
Hasan AKSOY, Dr. principal investigator
Istanbul Medeniyet University
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 Covid19 and Telogen Effluvium, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 6 Apr 2021. 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 Turkey (Türkiye). 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 Umut Mert YILDIRIM, Dr. (+905423383842, umutmertyildirim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hair shedding (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04834102, which also lists 4 linked publications.
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 6 Apr 2021.