Skin InflammationNCT06625918
Effects of Ultraviolet B Exposure Using a Ultraviolet Skin Care Device on Vitamin D Production and Immune Response in Healthy Adults
A study testing Ultraviolet B exposure to produce vitamin D synthesis in people with Skin Inflammation and Skin Melanoma, run by Wonju Severance Christian Hospital at 1 site in South Korea.
Trial summary
Vitamin D regulates various physiological functions, including calcium homeostasis, bone health, and potentially reducing cancer risks. Its primary source is Ultraviolet B radiation, but factors like aging, skin type, and modern lifestyles limit sun exposure, leading to widespread deficiency. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Inflammation, Skin Melanoma
- What is being tested?
- Ultraviolet B exposure to produce vitamin D synthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Mar 2024to 30 Sep 2024
- Phase
- Interventional
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ranges 19-65 years Healthy participants Patients who are willing or able to follow the doctor's instructions Fully understand the purpose and procedure of this clinical trial
Who cannot join
- Participants excluded those who have any kind of disease Lactating and pregnant women Physical disabilities that could interfere with participation, a history of depression, or other psychiatric conditions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigator-led Clinical Trial to Study the Effects of Ultraviolet Exposure Using a Ultraviolet B Skin Care Device on Vitamin D Production and Immune Response in Healthy Adults
Vitamin D regulates various physiological functions, including calcium homeostasis, bone health, and potentially reducing cancer risks. Its primary source is Ultraviolet B radiation, but factors like aging, skin type, and modern lifestyles limit sun exposure, leading to widespread deficiency. This study explores using a daily Ultraviolet B Light Emitting Diodes device to improve vitamin D levels while assessing the potential for skin inflammation.
- Conditions
- Skin Inflammation, Skin Melanoma
- Being tested
- Ultraviolet B exposure to produce vitamin D synthesis
- Medical subject headings
- Dermatitis, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultraviolet B exposure to produce vitamin D synthesisDevice
Exposure using a UV skin care device on vitamin D production and immune response in healthy adults
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Single group
Treatment Receives: Device: Ultraviolet B exposure to produce vitamin D synthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Total white blood cells its differential
2 weeks and 4 weeks treatment of total white blood cells and its differential counts such as eosinophils, basophils, lymphocytes, etc from baseline
Measured: 2 weeks and 4 weeks
Secondary outcomes (1)
Measurement of oxidative and inflammatory markers
2 weeks and 4 weeks treatment of oxidative markers such as reactive oxygen species, nitric oxide, glutathione peroxidase, and inflammatory cytokines such as tumor necrosis factor-α (TNF-α), interleukin (IL)-1β, IL-6, and IL-10, etc.
Measured: 2 weeks and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start20 Mar 2024
- Primary completion29 Apr 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin InflammationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wonju Severance Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyu Jae Lee, Wonju Severance Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625918
- Sponsor's protocol ID
- EMB-2023-12
- Status last verified
- Oct 2024
- First submitted
- 2 Oct 2024
- Last updated
- 15 Apr 2025
- 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 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-led Clinical Trial to Study the Effects of Ultraviolet Exposure Using a Ultraviolet B Skin Care Device on Vitamin D Production and Immune Response in Healthy Adults
- ClinicalTrials.gov ID
- NCT06625918
- Acronym / sponsor ID
- EMB-2023-12
- Conditions
- Skin Inflammation, Skin Melanoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Wonju Severance Christian HospitalUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 3 Oct 2024 (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 regulates various physiological functions, including calcium homeostasis, bone health, and potentially reducing cancer risks. Its primary source is Ultraviolet B radiation, but factors like aging, skin type, and modern lifestyles limit sun exposure, leading to widespread deficiency. This study explores using a daily Ultraviolet B Light Emitting Diodes device to improve vitamin D levels while assessing the potential for skin inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Device: Ultraviolet B exposure to produce vitamin D synthesisSingle group Treatment |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age ranges 19-65 years Healthy participants Patients who are willing or able to follow the doctor's instructions Fully understand the purpose and procedure of this clinical trial
Key exclusion criteria (1 listed)
- Participants excluded those who have any kind of disease Lactating and pregnant women Physical disabilities that could interfere with participation, a history of depression, or other psychiatric conditions
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 |
|---|---|---|
| Ultraviolet B exposure to produce vitamin D synthesisExposure using a UV skin care device on vitamin D production and immune response in healthy adults | Device | Single arm |
Primary outcome
Measurement of Total white blood cells its differential
Time frame: 2 weeks and 4 weeks
2 weeks and 4 weeks treatment of total white blood cells and its differential counts such as eosinophils, basophils, lymphocytes, etc from baseline
1 secondary outcome
Measurement of oxidative and inflammatory markers
Time frame: 2 weeks and 4 weeks
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 15 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Skin Inflammation
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingPhase 1
A Study of HSK60002 Tablets in Participants With Moderate-to-Severe Atopic Dermatitis
Dermatitis Atopic
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Moderate-to Severe Eczema
Atopic Dermatitis
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?
A study testing Ultraviolet B exposure to produce vitamin D synthesis in people with Skin Inflammation and Skin Melanoma, run by Wonju Severance Christian Hospital at 1 site in South Korea.
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: finished, as of the sponsor's last update on 15 Apr 2025. 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 South Korea. 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?
Measurement of Total white blood cells its differential (time frame: 2 weeks and 4 weeks). 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 Apr 2025.