UVB Phototherapy BurnEarly Phase 1NCT03932162
Gene Expression Changes In Young and Geriatric Skin
A Early Phase 1 study testing Insulin-Like Growth Factor 1 and No Insulin-Lie Growth Factor 1 in people with UVB Phototherapy Burn and Insulin-like Growth Factor 1, run by Wright State University at 1 site in United States.
Trial summary
This study does not involve any particular diagnosis. The goal of this research study is to explore the effects of artificial sunlight (ultraviolet B radiation; UVB) on the skin of young adults versus geriatric adults. Sunlight exerts many effects on the body. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- UVB Phototherapy Burn, Insulin-like Growth Factor 1, Aging
- What is being tested?
- Insulin-Like Growth Factor 1 and No Insulin-Lie Growth Factor 1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2019to Dec 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male/Female
- White skin (Fitzpatrick types I and II)
- Age 21-30 or 65 and older
- Able to comprehend procedures/risks
Who cannot join
- Known photosensitivity
- Currently on photosensitizing medications
- Diabetes Mellitus
- History of abnormal scarring
- History of skin infections
- Known allergy to lidocaine local anesthetic
- Pregnancy or nursing
- Other serious health issues
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wright State Physicians
Fairborn, Ohio, 45324
About this study
Official title: Gene Expression Changes in Young and Geriatric Skin
This study does not involve any particular diagnosis. The goal of this research study is to explore the effects of artificial sunlight (ultraviolet B radiation; UVB) on the skin of young adults versus geriatric adults. Sunlight exerts many effects on the body. There is evidence that in response to ultraviolet B radiation (UVB), which are the burning rays of sunlight, young adult skin responds differently than geriatric skin. In fact, researchers feel that this difference in how the skin reacts to UVB is why skin cancers are found in older skin. Researchers believe that a major difference between young adult and geriatric skin is that young skin has a lot of a protein called insulin-like growth factor-1 (IGF-1), whereas geriatric skin has very little. The current study will test how young adult versus geriatric skin responds to UVB, and if geriatric skin treated with an injection of small amount of IGF-1 drug will then act like young skin.
- Conditions
- UVB Phototherapy Burn, Insulin-like Growth Factor 1, Aging
- Being tested
- Insulin-Like Growth Factor 1, No Insulin-Lie Growth Factor 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin-Like Growth Factor 1Drug
Growth factor protein
No Insulin-Lie Growth Factor 1Other
No Insulin-Like Growth Factor 1 will be given.
| Study group | Role | What they receive |
|---|---|---|
| Young Adult | Placebo comparator | One small area of skin will undergo treatment with a small amount of UVB. Receives: Other: No Insulin-Lie Growth Factor 1 |
| Geriatric Adult | Active comparator | Four small areas will undergo injection of a small amount of IGF-1 drug and two will undergo injections with saline. Then the injected areas will be treated with a small amount of UVB. Receives: Drug: Insulin-Like Growth Factor 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in expression genes involved in protecting skin cells from UVB damage in younger skin and geriatric skin injected with IGF-1 from baseline
Expression genes involved in protecting skin cells from UVB damage, including p21, xeroderma pigmentosum (XPC), and polymerase eta, will be higher following UVB exposure in younger skin and geriatric skin injected with IGF-1 than in geriatric skin injected with saline as a control.
Measured: 2 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start6 Sep 2019
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UVB Phototherapy BurnStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
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
- NCT03932162
- Sponsor's protocol ID
- 06694
- Status last verified
- Feb 2025
- First submitted
- 26 Apr 2019
- Last updated
- 6 Feb 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gene Expression Changes in Young and Geriatric Skin
- ClinicalTrials.gov ID
- NCT03932162
- Acronym / sponsor ID
- 06694
- Conditions
- UVB Phototherapy Burn, Insulin-like Growth Factor 1, Aging
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Wright State UniversityUniversity, hospital or other
- Study start
- 6 Sep 2019 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 30 Apr 2019 (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 does not involve any particular diagnosis. The goal of this research study is to explore the effects of artificial sunlight (ultraviolet B radiation; UVB) on the skin of young adults versus geriatric adults. Sunlight exerts many effects on the body. There is evidence that in response to ultraviolet B radiation (UVB), which are the burning rays of sunlight, young adult skin responds differently than geriatric skin. In fact, researchers feel that this difference in how the skin reacts to UVB is why skin cancers are found in older skin. Researchers believe that a major difference between young adult and geriatric skin is that young skin has a lot of a protein called insulin-like growth factor-1 (IGF-1), whereas geriatric skin has very little. The current study will test how young adult versus geriatric skin responds to UVB, and if geriatric skin treated with an injection of small amount of IGF-1 drug will then act like young skin.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young Adult | Placebo comparator | Other: No Insulin-Lie Growth Factor 1One small area of skin will undergo treatment with a small amount of UVB. |
| Geriatric Adult | Active comparator | Drug: Insulin-Like Growth Factor 1Four small areas will undergo injection of a small amount of IGF-1 drug and two will undergo injections with saline. Then the injected areas will be treated with a small amount of UVB. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male/Female
- White skin (Fitzpatrick types I and II)
- Age 21-30 or 65 and older
- Able to comprehend procedures/risks
Key exclusion criteria (8 listed)
- Known photosensitivity
- Currently on photosensitizing medications
- Diabetes Mellitus
- History of abnormal scarring
- History of skin infections
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 |
|---|---|---|
| Insulin-Like Growth Factor 1Growth factor protein | Drug | Geriatric Adult |
| No Insulin-Lie Growth Factor 1No Insulin-Like Growth Factor 1 will be given. | Other | Young Adult |
Primary outcome
Change in expression genes involved in protecting skin cells from UVB damage in younger skin and geriatric skin injected with IGF-1 from baseline
Time frame: 2 Days
Expression genes involved in protecting skin cells from UVB damage, including p21, xeroderma pigmentosum (XPC), and polymerase eta, will be higher following UVB exposure in younger skin and geriatric skin injected with IGF-1 than in geriatric skin injected with saline as a control.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
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.
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 Early Phase 1 study testing Insulin-Like Growth Factor 1 and No Insulin-Lie Growth Factor 1 in people with UVB Phototherapy Burn and Insulin-like Growth Factor 1, 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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 6 Feb 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 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manager, Clinical Research Operations (937-245-7500, pturesearch@wrightstatephysicians.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in expression genes involved in protecting skin cells from UVB damage in younger skin and geriatric skin injected with IGF-1 from baseline (time frame: 2 Days). 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 6 Feb 2025.