Environmental ExposureNCT02529748
Pilot Study to Assess the Quantitative Dermal Transfer Efficiencies of Solids for Multiple Transfer Pathways
A study testing Participants for Surface Skin Sampling, Elemental metallic lead and Tinopal in people with Environmental Exposure, run by University of Minnesota at 1 site in United States.
Trial summary
Dermal transfer efficiency has been defined as the amount of material that moves from one surface to another following contact. The investigators propose to measure dermal transfer efficiency for the following pathways: (1) object to skin, (2) skin to skin, (3) skin to mouth, (4) clothing to skin, (5) gloves to skin… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Environmental Exposure
- What is being tested?
- Participants for Surface Skin Sampling, Elemental metallic lead and Tinopal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2015to 31 Jul 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult volunteers with healthy intact skin.
Who cannot join
- Children will be excluded from the study.
- Adults with a past history of dermal sensitization, skin allergy, or dermal irritation or dermatitis because of the potential to have compromised barrier function in the skin.
- Adults who are unwilling to follow protocol requirements.
- Adults who have a documented history of lead poisoning.
- Adults who have a concurrent contagious illness or other stressor which in the opinion of the investigator may interfere with the subject's ability to perform the study's requirements.
- Adults who have open wounds or otherwise compromised skin integrity on their hands.
- Adults who are pregnant or nursing.
- Adults who lack the capacity to provide informed voluntary consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Dermal transfer efficiency has been defined as the amount of material that moves from one surface to another following contact. The investigators propose to measure dermal transfer efficiency for the following pathways: (1) object to skin, (2) skin to skin, (3) skin to mouth, (4) clothing to skin, (5) gloves to skin, and (6) air to skin. First, the quantitative dermal transfer will be measured for the two selected test substances (lead, Tinopal) for each of these six pathways. The relative quantities of dermal transfer will also then be compared between the different transfer pathways (e.g., is skin to skin transfer greater or less than clothing to skin transfer?). And second, the pattern of transfer will be characterized semi-quantitatively (e.g., does dermal transfer occur consistently and evenly to the skin from different reservoirs?).
Read the detailed description
Each of the six transfer pathways will be tested and measured in a controlled, ventilated study chamber at the University of Minnesota's School of Public Health Industrial Hygiene Laboratory. To test each pathway, human volunteers will perform repeated contact activities using an identical protocol (e.g., identical number of contacts, type of material contacted, measured pressure of contact, measured time of contact, measured temperature and humidity) so that inter- and intra-individual variability can be characterized.
The qualitative and quantitative sampling methods that will be used have been developed, tested, and published by researchers from the National Institute for Occupational Safety and Health (NIOSH) and other institutions such as ASTM. Specifically, quantitative transfer efficiencies will be measured using accepted wipe sampling protocols taken from several papers in the peer-reviewed literature. Semi-quantitative transfer patterns will be measured using fluorescent tracer intensity techniques that have also been presented in the peer-reviewed literature. The skin surface wipe samples will be sent to an accredited American Industrial Hygiene Association (AIHA) laboratory for analysis.
These sampling results will allow the investigators to report the measured quantitative dermal transfer efficiencies of elemental metallic lead and Tinopal for each pathway in mass per square surface area of skin, and also calculate the relative transfer efficiencies in terms of percent transferred versus originally loaded. Fluorescent tracer maps will allow the investigators to demonstrate the patterns of transfer for each pathway using intensity of the tracer following transfer. Following this analysis, the investigators will then use the data to better inform the relative importance of the pathways in the conceptual model with respect to dermal exposure assessment and modeling efforts. These results are very important for improving the quality of workplace dermal exposure assessments and techniques. The current approaches are not well validated, and it is unknown if the results of existing dermal exposure models are accurate. It is expected that the results of this study will help to improve the protection of workers from certain dermal exposure hazards in the workplace by providing better inputs to the existing dermal exposure models, since it is not possible to collect exposure samples for each job task in the workplace.
- Conditions
- Environmental Exposure
- Being tested
- Participants for Surface Skin Sampling, Elemental metallic lead, Tinopal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants for Surface Skin SamplingOther
Also called No other names
Skin wipe samples will be collected to quantify the amount of the test substances transferred to and from the surface of the participants' skin.
Elemental metallic leadOther
Also called No other names
Consumer product fishing tackle made of elemental lead will be handled by the participants.
TinopalOther
Also called No other names
Tinopal, a fluorescent tracer, will be handled by the participants.
| Study group | Role | What they receive |
|---|---|---|
| Participants for Surface Skin Sampling | Experimental | Adult volunteers with healthy, intact skin will have surface skin wipe samples collected following contact with the approved test substances to measure the quantitative transfer of the test substances to and from the skin surface. Receives: Other: Participants for Surface Skin Sampling; Other: Elemental metallic lead; Other: Tinopal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative mass of test substance per area of skin as measured through surface sampling
Participants will handle or touch the approved test substances or an intermediate transfer material such as a solid surface or clothing. Surface skin wipe sampling will then be conducted to measure the amount of material that has been transferred to or from the skin surface.
Measured: Surface samples will be collected within an hour of contact or application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study start1 Aug 2015
- Primary completion31 Jul 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Environmental ExposureStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02529748
- Sponsor's protocol ID
- 1506M73781
- Status last verified
- Aug 2019
- First submitted
- 11 Aug 2015
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess the Quantitative Dermal Transfer Efficiencies of Solids for Multiple Transfer Pathways
- ClinicalTrials.gov ID
- NCT02529748
- Acronym / sponsor ID
- 1506M73781
- Conditions
- Environmental Exposure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 20 Aug 2015 (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.
Dermal transfer efficiency has been defined as the amount of material that moves from one surface to another following contact. The investigators propose to measure dermal transfer efficiency for the following pathways: (1) object to skin, (2) skin to skin, (3) skin to mouth, (4) clothing to skin, (5) gloves to skin, and (6) air to skin. First, the quantitative dermal transfer will be measured for the two selected test substances (lead, Tinopal) for each of these six pathways. The relative quantities of dermal transfer will also then be compared between the different transfer pathways (e.g., is skin to skin transfer greater or less than clothing to skin transfer?). And second, the pattern of transfer will be characterized semi-quantitatively (e.g., does dermal transfer occur consistently and evenly to the skin from different reservoirs?).
Detailed description
Each of the six transfer pathways will be tested and measured in a controlled, ventilated study chamber at the University of Minnesota's School of Public Health Industrial Hygiene Laboratory. To test each pathway, human volunteers will perform repeated contact activities using an identical protocol (e.g., identical number of contacts, type of material contacted, measured pressure of contact, measured time of contact, measured temperature and humidity) so that inter- and intra-individual variability can be characterized.
The qualitative and quantitative sampling methods that will be used have been developed, tested, and published by researchers from the National Institute for Occupational Safety and Health (NIOSH) and other institutions such as ASTM. Specifically, quantitative transfer efficiencies will be measured using accepted wipe sampling protocols taken from several papers in the peer-reviewed literature. Semi-quantitative transfer patterns will be measured using fluorescent tracer intensity techniques that have also been presented in the peer-reviewed literature. The skin surface wipe samples will be sent to an accredited American Industrial Hygiene Association (AIHA) laboratory for analysis.
These sampling results will allow the investigators to report the measured quantitative dermal transfer efficiencies of elemental metallic lead and Tinopal for each pathway in mass per square surface area of skin, and also calculate the relative transfer efficiencies in terms of percent transferred versus originally loaded. Fluorescent tracer maps will allow the investigators to demonstrate the patterns of transfer for each pathway using intensity of the tracer following transfer. Following this analysis, the investigators will then use the data to better inform the relative importance of the pathways in the conceptual model with respect to dermal exposure assessment and modeling efforts. These results are very important for improving the quality of workplace dermal exposure assessments and techniques. The current approaches are not well validated, and it is unknown if the results of existing dermal exposure models are accurate. It is expected that the results of this study will help to improve the protection of workers from certain dermal exposure hazards in the workplace by providing better inputs to the existing dermal exposure models, since it is not possible to collect exposure samples for each job task in the workplace.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants for Surface Skin Sampling | Experimental | Other: Participants for Surface Skin Sampling, Other: Elemental metallic lead, Other: TinopalAdult volunteers with healthy, intact skin will have surface skin wipe samples collected following contact with the approved test substances to measure the quantitative transfer of the test substances to and from the skin surface. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult volunteers with healthy intact skin.
Key exclusion criteria (8 listed)
- Children will be excluded from the study.
- Adults with a past history of dermal sensitization, skin allergy, or dermal irritation or dermatitis because of the potential to have compromised barrier function in the skin.
- Adults who are unwilling to follow protocol requirements.
- Adults who have a documented history of lead poisoning.
- Adults who have a concurrent contagious illness or other stressor which in the opinion of the investigator may interfere with the subject's ability to perform the study's requirements.
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 |
|---|---|---|
| Participants for Surface Skin SamplingAlso: No other namesSkin wipe samples will be collected to quantify the amount of the test substances transferred to and from the surface of the participants' skin. | Other | Participants for Surface Skin Sampling |
| Elemental metallic leadAlso: No other namesConsumer product fishing tackle made of elemental lead will be handled by the participants. | Other | Participants for Surface Skin Sampling |
| TinopalAlso: No other namesTinopal, a fluorescent tracer, will be handled by the participants. | Other | Participants for Surface Skin Sampling |
Primary outcome
Quantitative mass of test substance per area of skin as measured through surface sampling
Time frame: Surface samples will be collected within an hour of contact or application
Participants will handle or touch the approved test substances or an intermediate transfer material such as a solid surface or clothing. Surface skin wipe sampling will then be conducted to measure the amount of material that has been transferred to or from the skin surface.
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 Aug 2019.
Related trials for Environmental Exposure
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingObservational study
Natural History of the Human Biological Response to Environmental Exposure and Injury
Inflammation, Normal Controls
RecruitingObservational study
NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)
Asthma
Recruiting
Ambient Air and Noise Effect on Cardiovascular Health Risk and Lifestyle Intervention to Attenuate It (METSGREEN)
Cardiovascular Diseases (CVD), Metabolic Syndrome
Recruiting
Lungs on Fire: Wildfire Smoke, Incident Diseases, Susceptible Populations, and Community Values in Canada
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
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 Participants for Surface Skin Sampling, Elemental metallic lead and Tinopal in people with Environmental Exposure, 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 1 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: finished, as of the sponsor's last update on 15 Aug 2019. 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.
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?
Quantitative mass of test substance per area of skin as measured through surface sampling (time frame: Surface samples will be collected within an hour of contact or application). 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 Aug 2019.