Efficacy Study of a Nicotine Barrier Cream

Details

• Personal Author:
  Biswas S ; Davis VG ; Klingner T ; Liu Y ; Pears R ; Prince TS ; Reed D ; Sterling D ; Stinchcomb A
• Description:
  In September, 2013, the University of North Texas Health Science Center received the R03OH009815 grant from the CDC/NIOS and initiated the efficacy study of a nicotine barrier cream, with the goal of developing a barrier cream and assessing the efficacy, acceptability, side effects and ease of use in in vitro testing and in a pilot field study. Aims: The main objective of this study was to develop a barrier cream and evaluate its efficacy in the laboratory and conduct a small field study to evaluate its efficacy in reducing nicotine exposure from tobacco harvesting workers in tobacco farms in Kentucky. Our specific aims were as follows: Aim 1: To develop a nicotine barrier cream and identify optimal formulations in the laboratory. Aim 2: To assess its efficacy in reducing dermal absorption of nicotine using in vitro testing. Aim 3: To evaluate its efficacy, acceptance, side effects and feasibility in a field pilot study. Methods: The study included three closely related, but separate, parts designed to achieve the three specific aims: development and optimization of barrier cream formulations performed by Colormetric Laboratories, Inc.; efficacy study by in vitro testing conducted by the University of Maryland at Baltimore and pilot field study in tobacco farms with tobacco farm workers conducted by the University of North Texas Health Science Center (UNTHSC) in collaboration with researchers at the University of Kentucky at Lexington and the University of Texas at Dallas. The development of formulations was based on acidic components in the cream which were adjusted based on the in vitro testing to achieve optimal efficacy in reducing permeation of nicotine. The in vitro testing used miniature pig skin, a PermeGear flow-through diffusion cell system with L-nicotine solution and tobacco extract as nicotine donors and high performance liquid chromatography (HPLC) for analysis on permeated nicotine through the formulation-treated skin or control skin. Formulation-treated cotton gloves were also tested on their efficacy as a potential tool for skin protection. The field pilot testing recruited migrant tobacco farm workers, and used two best formulations from the in vitro testing to compare the efficacy between non-use and use time periods of the study week and between two formulations. Post-shift urine samples were collected from all workers and analyzed for urinary nicotine and cotinine adjusted for creatinine amount and body surface area. Two-sample t test, analysis of variance (ANOVA) and mixed effect modeling were used in the data analysis. Results: Four formulations of the cream with various acid components were developed which were all found to reduce nicotine permeation in vitro. The best barrier cream formulations reduced in vitro skin permeation of nicotine by 97.6% from L-nicotine, by 64.0% from green tobacco leaf extract and by 86.6% from green tobacco leaf extract for gardening gloves coated with the barrier cream. A total of 43 workers from 6 farms participated in the field study. Gender, age, education, tasks performed during harvesting and barrier cream use, were identified as predictors of nicotine exposure. The nicotine formulations were well accepted by workers although the efficacy was not yet optimal. Conclusion: The developed barrier cream formulations have the potential to reduce nicotine permeation through the skin. However, the current study is limited in its design and did not show its optimal efficacy. Further studies with improved design, large sample size and pre-shift urine samples to analyze for cross-shift comparison are recommended. [Description provided by NIOSH]
• Subjects:
  Aging Agriculture Environmental Exposure Farmers Laboratories Men Nicotine Occupational Health Personal Protective Equipment Preceptorship Preventive Medicine Safety Skin Tobacco Products Urine Women Workplace

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• Keywords:
  Age Groups Agricultural Agricultural Workers Dermal Exposures Effectiveness Research Exposure Levels Farm Workers Field Study Gloves Health Effects Humans In Vitro Study Models Preventive Medicine Safety Practices Skin Exposure Skin Protection Skin Tests Statistical Analysis Tobacco Urinalysis Work Environment Workers

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• Series:
  Grant Final Reports
• Publisher:
  National Institute for Occupational Safety and Health
• Document Type:
  Text
• Funding:
  Grant
• Genre:
  Final Grant Report
• Place as Subject:
  Illinois ; Kentucky ; OSHA Region 4 ; OSHA Region 5 ; OSHA Region 6 ; Texas
• CIO:
  National Institute for Occupational Safety and Health (NIOSH)
• Division:
  OEP - Office of Extramural Programs
• Topic:
  Workplace Safety & Health
• Location:
  North America
• Pages in Document:
  1-48
• NIOSHTIC Number:
  nn:20049668
• Citation:
  Atlanta, GA: U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control, National Institute for Occupational Safety and Health, R03-OH-009815, 2016 Dec; :1-48
• Contact Point Address:
  Youcheng Liu, M.D., Sc.D., M.P.H., M., Department of Environmental and Occupational Health Sciences, School of Public Health, University of North Texas Health Science Center, 3500 Camp Bowie Blvd, Fort Worth, TX 76132
• Email:
  youcheng.liu@unthsc.edu
• Federal Fiscal Year:
  2017
• Performing Organization:
  University of North Texas Health Science Center, Fort Worth, Texas
• Peer Reviewed:
  False
• Start Date:
  20130901
• Source Full Name:
  National Institute for Occupational Safety and Health
• End Date:
  20160831
• Collection(s):
  National Institute for Occupational Safety and Health
• Main Document Checksum:
  urn:sha-512:eece1350a0efdf4427797744919b9bccf690d06dc878c1cf3e6522f68813389788550c7bf1a025fffbcc23d771db2f6fd631cce11050aa5b26e7017949ef3816
• Download URL:
  https://stacks.cdc.gov/view/cdc/218657/cdc_218657_DS1.pdf
• File Type:
  [PDF - 4.72 MB ]