ProteomicsEarly Phase 1NCT00397436
Pilot Study of Protein Profiling of the Human Epidermal Cells After Ultraviolet Irradiation
A Early Phase 1 study testing UV Irradiation in people with Proteomics, run by University of Minnesota at 1 site in United States.
Trial summary
The main focus of this pilot study is to construct a fairly complete protein profile of the epidermis. This will allow us to study how the epidermis responds to external stressors such as ultra-violet. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Proteomics
- What is being tested?
- UV Irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Dec 2015
- Phase
- Early 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Males age 18-30
- Caucasian
- No neurological disease
Who cannot join
- Use of any medication that affects skin
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
The main focus of this pilot study is to construct a fairly complete protein profile of the epidermis. This will allow us to study how the epidermis responds to external stressors such as ultra-violet. We hypothesize that by using the cutting edge technology, proteomics, we will be able to construct a fairly complete profile of different epidermal cells (keratinocytes, epidermal nerve fibers (ENFs), melanocytes, Langerhans cell,...etc) of normal and ultraviolet (UV) irradiated skin.
Read the detailed description
We will investigate the changes of the epidermal cell proteome after UV irradiation to the forearms of healthy young male volunteers. Knowledge of specific molecular markers may provide knowledge of basic biological systems and possibly targeted therapy of inflammation.
By using combined proteomic methodologies we will be able to quantify protein changes at cytoplasmic and membrane protein levels of epidermal cells in normal vs. irradiated skins.
This study may allow us to obtain fairly comprehensive profile of membrane integrated and cytoplasmic proteins of epidermal cell populations which will facilitate our understand of biological responses to UV irradiation.
- Conditions
- Proteomics
- Being tested
- UV Irradiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UV IrradiationProcedure or surgery
Also called UV irradiation.
UV irradiation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Comparing irradiated skin to non irradiated skin. Receives: Procedure: UV Irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to quantify protein changes at cytoplasmic and membrane protein levels of epidermal cells in normal vs. irradiated skin
Measured: 1 year
Secondary outcomes (1)
Obtain a profile of membrane integrated and cytoplasmic proteins of epidermal cell populations which will facilitate our understanding of biological responses to UV irradiation.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2006 (estimated)
- Study startFeb 2007
- Primary completionNov 2011
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ProteomicsStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- George Wilcox, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00397436
- Sponsor's protocol ID
- 0506M70827
- Status last verified
- May 2016
- First submitted
- 7 Nov 2006
- Last updated
- 17 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Protein Profiling of the Human Epidermal Cells After Ultraviolet Irradiation
- ClinicalTrials.gov ID
- NCT00397436
- Acronym / sponsor ID
- 0506M70827
- Conditions
- Proteomics
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 9 Nov 2006 (estimated)
- 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.
The main focus of this pilot study is to construct a fairly complete protein profile of the epidermis. This will allow us to study how the epidermis responds to external stressors such as ultra-violet. We hypothesize that by using the cutting edge technology, proteomics, we will be able to construct a fairly complete profile of different epidermal cells (keratinocytes, epidermal nerve fibers (ENFs), melanocytes, Langerhans cell,...etc) of normal and ultraviolet (UV) irradiated skin.
Detailed description
We will investigate the changes of the epidermal cell proteome after UV irradiation to the forearms of healthy young male volunteers. Knowledge of specific molecular markers may provide knowledge of basic biological systems and possibly targeted therapy of inflammation.
By using combined proteomic methodologies we will be able to quantify protein changes at cytoplasmic and membrane protein levels of epidermal cells in normal vs. irradiated skins.
This study may allow us to obtain fairly comprehensive profile of membrane integrated and cytoplasmic proteins of epidermal cell populations which will facilitate our understand of biological responses to UV irradiation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: UV IrradiationComparing irradiated skin to non irradiated skin. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Males age 18-30
- Caucasian
- No neurological disease
Key exclusion criteria (1 listed)
- Use of any medication that affects skin
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 |
|---|---|---|
| UV IrradiationAlso: UV irradiation.UV irradiation | Procedure or surgery | 1 |
Primary outcome
Ability to quantify protein changes at cytoplasmic and membrane protein levels of epidermal cells in normal vs. irradiated skin
Time frame: 1 year
1 secondary outcome
Obtain a profile of membrane integrated and cytoplasmic proteins of epidermal cell populations which will facilitate our understanding of biological responses to UV irradiation.
Time frame: 1 year
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 17 May 2016.
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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.
George Wilcox, PhD principal investigator
University of Minnesota
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 UV Irradiation in people with Proteomics, run by University of Minnesota 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 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 17 May 2016. 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?
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?
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?
Ability to quantify protein changes at cytoplasmic and membrane protein levels of epidermal cells in normal vs. irradiated skin (time frame: 1 year). 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 17 May 2016.