Ultraviolet B RadiationPhase 1NCT05734235
UVB-Induced MVP Release in Human Skin
A Phase 1 study testing Vitamin C and Vitamin E in people with Ultraviolet B Radiation and Microvesicle Particles, run by Wright State University at 1 site in United States.
Trial summary
This study is designed to assess if ultraviolet B radiation (UVB) found in sunlight causes the release of microvesicle particles in human skin, and if antioxidant vitamins can block their production. Read more about this study
- Who is it for?
- Ages 21 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Ultraviolet B Radiation, Microvesicle Particles
- What is being tested?
- Vitamin C and Vitamin E
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jul 2018to 26 Oct 2022
- Phase
- Phase 1
- 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 21 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male subjects
- Ages 21 to 45
- Skin type: Fitzpatrick Type I or II
Who cannot join
- Have underlying diseases that could affect wound healing
- On medications that are known photosensitizers (e.g., doxycycline) or anti-inflammatories (e.g., NSAIDS [except for low-dose aspirin] or steroids)
- History of abnormal scarring (e.g., keloids)
- Should not be on Vitamin C or E supplements for past month
- Unable to understand/complete informed consent
- Large volar arm tattoos that would inhibit the ability to conduct/evaluate the skin testing
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- Renal compromise/kidney stones or allergy to Vitamin C/Vitamin E or lidocaine anaesthetic
- Use of tanning bends or recent UVB exposure to the areas in the past 3 months
- Recent (within 1 week) use to sunscreen to volar forearms
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultraviolet B Radiation-Induced Microvesicle Particle Release in Human Skin
This study is designed to assess if ultraviolet B radiation (UVB) found in sunlight causes the release of microvesicle particles in human skin, and if antioxidant vitamins can block their production.
- Conditions
- Ultraviolet B Radiation, Microvesicle Particles
- Being tested
- Vitamin C, Vitamin E
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDietary supplement
Two Vitamin C tablets daily for 8 days.
Vitamin EDietary supplement
One Vitamin E tablet daily for 8 days.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin C & Vitamin E | Experimental | After subjects undergo UVB treatment then they will be instructed to take two Vitamin C and one Vitamin E tablets daily for 8 days. Receives: Dietary Supplement: Vitamin C; Dietary Supplement: Vitamin E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in microvesicle particles (MVP) levels from baseline
Levels of microvesicle particles will be determined from skin biopsies
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start16 Jul 2018
- Primary completion5 Mar 2020
- Study completion26 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ultraviolet B RadiationStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wright State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey B Travers, MD, PhD, Principal investigator, Wright State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734235
- Sponsor's protocol ID
- 06201
- Status last verified
- Feb 2023
- First submitted
- 8 Feb 2023
- Last updated
- 24 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultraviolet B Radiation-Induced Microvesicle Particle Release in Human Skin
- ClinicalTrials.gov ID
- NCT05734235
- Acronym / sponsor ID
- 06201
- Conditions
- Ultraviolet B Radiation, Microvesicle Particles
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Wright State UniversityUniversity, hospital or other
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 17 Feb 2023 (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 is designed to assess if ultraviolet B radiation (UVB) found in sunlight causes the release of microvesicle particles in human skin, and if antioxidant vitamins can block their production.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vitamin C & Vitamin E | Experimental | Dietary Supplement: Vitamin C, Dietary Supplement: Vitamin EAfter subjects undergo UVB treatment then they will be instructed to take two Vitamin C and one Vitamin E tablets daily for 8 days. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male subjects
- Ages 21 to 45
- Skin type: Fitzpatrick Type I or II
Key exclusion criteria (9 listed)
- Have underlying diseases that could affect wound healing
- On medications that are known photosensitizers (e.g., doxycycline) or anti-inflammatories (e.g., NSAIDS [except for low-dose aspirin] or steroids)
- History of abnormal scarring (e.g., keloids)
- Should not be on Vitamin C or E supplements for past month
- Unable to understand/complete informed consent
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 |
|---|---|---|
| Vitamin CTwo Vitamin C tablets daily for 8 days. | Dietary supplement | Vitamin C & Vitamin E |
| Vitamin EOne Vitamin E tablet daily for 8 days. | Dietary supplement | Vitamin C & Vitamin E |
Primary outcome
Change in microvesicle particles (MVP) levels from baseline
Time frame: Day 8
Levels of microvesicle particles will be determined from skin biopsies
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 24 Feb 2023.
Related trials for Ultraviolet B Radiation
Recruiting
Title: ICARUS - Psycho-physiological Profiling of Low and High Heat-resilient Individuals
Skin Cancer, Heat Tolerance
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.
Jeffrey B Travers, MD, PhD principal investigator
Wright State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vitamin C and Vitamin E in people with Ultraviolet B Radiation and Microvesicle Particles, run by Wright State University at 1 site in United States.
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 3 inclusion and 9 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 24 Feb 2023. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 microvesicle particles (MVP) levels from baseline (time frame: Day 8). 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 24 Feb 2023; AzTrials last refreshed its copy on 31 Oct 2026.