Acne VulgarisNCT05398939
Impact of COVID-19 Vaccination on Serum 25-hydroxyvitamin D Level
An observational study of Acne Vulgaris and Vitamin D Deficiency, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Vitamin D plays a pivotal but still not well understood role in the immune response to coronavirus disease (COVID-19) infection and vaccination. Many studies also showed a high negative correlation between the severity of inflammatory disease and serum 25-hydroxyvitamin D levels. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Acne Vulgaris, Vitamin D Deficiency, COVID-19
- What is being tested?
- Blood test and skin evaluation
- Type of treatment
- Vaccines
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 May 2022to 29 Nov 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 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: The adults with acne vulgaris who are going to receive the third dose of COVID-19 vaccine.
Who may be able to join
- Age of ≥ 20 years and < 65 years
- Diagnosis of acne vulgaris
- The one will receive the third dose of COVID-19 vaccine
- Signing informed consent
Who cannot join
- History of COVID-19 infection
- Currently taking vitamin-D, steroid, or any drugs for acne vulgaris.
- Coagulopathy
- Having any chronic inflammation disease, immunity-related disease, diabetes, mellitus, kidney disease, or liver disease.
- Have acute inflammation disease, for example, upper respiratory infection or urinary tract infection
- Pregnancy or lactation
- History of cancer or any major systematic disease
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Dermatology, National Taiwan University Hospital
Taipei
About this study
Vitamin D plays a pivotal but still not well understood role in the immune response to coronavirus disease (COVID-19) infection and vaccination. Many studies also showed a high negative correlation between the severity of inflammatory disease and serum 25-hydroxyvitamin D levels. Patients with acne vulgaris often had deteriorated skin condition after COVID-19 vaccination. Therefore, this study aimed to investigate the relationship of COVID-19 vaccination with serum 25-hydroxyvitamin D level and severity of acne vulgaris.
Read the detailed description
Vitamin D is known to be related with calcium and bone metabolism. Recently, vitamin D has been shown to play an important role in innate and acquired immunity, cytokine release, inflammatory response, and may be associated with a reduced risk of infection. Studies have reported that serum 25-hydroxyvitamin D concentrations are significantly lower in COVID-19 infected patients than in uninfected patients. In addition, it has been shown that people with higher serum 25-hydroxyvitamin D level would produce significantly more antibodies after COVID-19 vaccination.Thus, it is clear that vitamin D plays a pivotal but still not well understood role in the immune response to COVID-19 infection and vaccination.
Patients with inflammatory skin diseases (e.g., psoriasis, atopic dermatitis, acne vulgaris, hair loss, idiopathic urticaria, etc.) are often observed to have deteriorated skin condition after COVID-19 vaccination, which not only affects the patient's quality of life, but also seriously affects the patient's willingness to complete vaccination. Since many studies have shown a high negative correlation between the severity of inflammatory disease and serum 25-hydroxyvitamin D levels, it is likely that the COVID-19 vaccination also impacts serum 25-hydroxyvitamin D levels. Therefore, this study aimed to analyze the changes in serum 25-hydroxyvitamin D levels and acne severity in patients with acne vulgaris before and after the third dose of COVID-19 vaccine.
- Conditions
- Acne Vulgaris, Vitamin D Deficiency, COVID-19
- Being tested
- Blood test and skin evaluation
- Medical subject headings
- Acne Vulgaris, Vitamin D Deficiency, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood test and skin evaluationDiagnostic test
The patients received blood tests for serum 25-hydroxyvitamin D level and skin evaluation for severity of acne vulgaris and lesion counts.
| Study group | Role | What they receive |
|---|---|---|
| Acne cohort | Adults with acne vulgaris who are going to receive the third dose of COVID-19 vaccine. Receives: Diagnostic Test: Blood test and skin evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum 25-hydroxyvitamin D level
Blood test for serum 25-hydroxyvitamin D level
Measured: 7 days before and 28 days after the third dose of COVID-10 vaccine
Secondary outcomes (2)
Change in acne severity
Skin evaluation by the Global Acne Grading System
Measured: 7 days before and 28 days after the third dose of COVID-10 vaccine
Change in acne acne lesion counts
Counts of acne lesion
Measured: 7 days before and 28 days after the third dose of COVID-10 vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start25 May 2022
- Primary completion4 Jul 2022
- Study completion29 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chih-Chieh Chan, MD, Principal investigator, Department of Dermatology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05398939
- Sponsor's protocol ID
- 202204118RINC
- Status last verified
- Apr 2023
- First submitted
- 31 May 2022
- Last updated
- 16 Apr 2024
- 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 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of COVID-19 Vaccination on Serum 25-hydroxyvitamin D Level
- ClinicalTrials.gov ID
- NCT05398939
- Acronym / sponsor ID
- 202204118RINC
- Conditions
- Acne Vulgaris, Vitamin D Deficiency, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- 4 Jul 2022 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 1 Jun 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.
Vitamin D plays a pivotal but still not well understood role in the immune response to coronavirus disease (COVID-19) infection and vaccination. Many studies also showed a high negative correlation between the severity of inflammatory disease and serum 25-hydroxyvitamin D levels. Patients with acne vulgaris often had deteriorated skin condition after COVID-19 vaccination. Therefore, this study aimed to investigate the relationship of COVID-19 vaccination with serum 25-hydroxyvitamin D level and severity of acne vulgaris.
Detailed description
Vitamin D is known to be related with calcium and bone metabolism. Recently, vitamin D has been shown to play an important role in innate and acquired immunity, cytokine release, inflammatory response, and may be associated with a reduced risk of infection. Studies have reported that serum 25-hydroxyvitamin D concentrations are significantly lower in COVID-19 infected patients than in uninfected patients. In addition, it has been shown that people with higher serum 25-hydroxyvitamin D level would produce significantly more antibodies after COVID-19 vaccination.Thus, it is clear that vitamin D plays a pivotal but still not well understood role in the immune response to COVID-19 infection and vaccination.
Patients with inflammatory skin diseases (e.g., psoriasis, atopic dermatitis, acne vulgaris, hair loss, idiopathic urticaria, etc.) are often observed to have deteriorated skin condition after COVID-19 vaccination, which not only affects the patient's quality of life, but also seriously affects the patient's willingness to complete vaccination. Since many studies have shown a high negative correlation between the severity of inflammatory disease and serum 25-hydroxyvitamin D levels, it is likely that the COVID-19 vaccination also impacts serum 25-hydroxyvitamin D levels. Therefore, this study aimed to analyze the changes in serum 25-hydroxyvitamin D levels and acne severity in patients with acne vulgaris before and after the third dose of COVID-19 vaccine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acne cohort | – | Diagnostic Test: Blood test and skin evaluationAdults with acne vulgaris who are going to receive the third dose of COVID-19 vaccine. |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The adults with acne vulgaris who are going to receive the third dose of COVID-19 vaccine.
Key inclusion criteria (4 listed)
- Age of ≥ 20 years and < 65 years
- Diagnosis of acne vulgaris
- The one will receive the third dose of COVID-19 vaccine
- Signing informed consent
Key exclusion criteria (7 listed)
- History of COVID-19 infection
- Currently taking vitamin-D, steroid, or any drugs for acne vulgaris.
- Coagulopathy
- Having any chronic inflammation disease, immunity-related disease, diabetes, mellitus, kidney disease, or liver disease.
- Have acute inflammation disease, for example, upper respiratory infection or urinary tract infection
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 test and skin evaluationThe patients received blood tests for serum 25-hydroxyvitamin D level and skin evaluation for severity of acne vulgaris and lesion counts. | Diagnostic test | Acne cohort |
Primary outcome
Change in serum 25-hydroxyvitamin D level
Time frame: 7 days before and 28 days after the third dose of COVID-10 vaccine
Blood test for serum 25-hydroxyvitamin D level
2 secondary outcomes
Change in acne severity
Time frame: 7 days before and 28 days after the third dose of COVID-10 vaccine
Change in acne acne lesion counts
Time frame: 7 days before and 28 days after the third dose of COVID-10 vaccine
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 16 Apr 2024.
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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.
Chih-Chieh Chan, MD principal investigator
Department of Dermatology, National Taiwan University Hospital
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 Acne Vulgaris and Vitamin D Deficiency, run by National Taiwan University Hospital at 1 site in Taiwan.
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 7 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 16 Apr 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 Taiwan. 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?
Change in serum 25-hydroxyvitamin D level (time frame: 7 days before and 28 days after the third dose of COVID-10 vaccine). 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 16 Apr 2024.