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Transdermal Absorption of Dimercaptopropane-1-Sulfonate (DMPS) and Effect on Urinary Mercury Excretion

NCT01059474 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2011-06-22

No results posted yet for this study

Summary

DMPS is a metal chelator which is approved for use in Europe. While not an FDA-approved drug in the US, it is easily obtained and administered by alternative health practitioners to their patients. A formulation called 'TD DMPS' (transdermal DMPS) is in use, despite the fact there is no published literature to support that the agent is absorbed transdermally. The investigators hypothesis is that DMPS is not absorbed through the skin. The investigators plan to apply TD DMPS to healthy volunteers and then test serum for presence of DMPS. In addition the investigators will measure urinary mercury concentrations pre and post DMPS application.

Conditions

  • Toxicity

Interventions

DRUG

transdermal DMPS

12 hr urine mercury and creatinine levels will be measured on all volunteers prior to any treatment. The urine will be collected in acid-washed or heavy-metal-free specialty containers. Each volunteer will then receive 120 mg of transdermal DMPS, applied to the bicep area of one arm. The area of application will not exceed 2% body surface area. After dosing, urine will be collected for the next 12 hours (using the same protocol and send-out procedure) and assayed for mercury and creatinine levels. Additionally, after dosing, an intravenous catheter will be placed in the arm of each subject for blood draws. Blood samples will be obtained at 30 minutes, 60 minutes, 90 minutes, 2 hours, 4 hours and 6 hours after application of the DMPS.

Sponsors & Collaborators

  • Phoenix Children's Hospital

    collaborator OTHER

  • Banner Health

    lead OTHER

Principal Investigators

  • Anne-Michelle Ruha, M.D. · Banner Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01059474 on ClinicalTrials.gov