Pilot Study to Assess the Quantitative Dermal Transfer Efficiencies of Solids for Multiple Transfer Pathways

NCT02529748 | Completed

• 1 other identifier: 1506M73781
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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, 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?).

Conditions

Environmental Exposure

Outcome Measures

Primary Outcomes (1)

• 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.

  Surface samples will be collected within an hour of contact or application

Study Arms (1)

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.

Other: Participants for Surface Skin Sampling; Other: Elemental metallic lead; Other: Tinopal

Interventions

Participants for Surface Skin Sampling OTHER

Skin wipe samples will be collected to quantify the amount of the test substances transferred to and from the surface of the participants' skin.

Also known as: No other names

Participants for Surface Skin Sampling

Elemental metallic lead OTHER

Consumer product fishing tackle made of elemental lead will be handled by the participants.

Also known as: No other names

Participants for Surface Skin Sampling

Tinopal OTHER

Tinopal, a fluorescent tracer, will be handled by the participants.

Also known as: No other names

Participants for Surface Skin Sampling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult volunteers with healthy intact skin.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Interventions

Tinopal

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2015
• First Posted: August 20, 2015
• Study Start: August 1, 2015
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: August 15, 2019

Record last verified: 2019-08

Locations

US (1)