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Veron Scabies Education and Eradication Program (VSEEP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00604084
First Posted: January 29, 2008
Last Update Posted: March 10, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Edward Via Virginia College of Osteopathic Medicine
  Purpose
The purpose of this project is to develop a community scabies eradication and education program for the highly endemic areas surrounding the Veron community on the eastern tip of the Dominican Republic. It proposes the use of oral Ivermectin as a replacement for topical Lindane--a readily available medical formulation, pesticide, and environmental toxin that is reported to be banned in the Dominican Republic as well as over 80 other countries throughout the world.

Condition Intervention
Scabies Drug: Ivermectin Drug: Permethrin 5% lotion

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Veron Scabies Education and Eradication Program

Resource links provided by NLM:


Further study details as provided by Edward Via Virginia College of Osteopathic Medicine:

Primary Outcome Measures:
  • Scabies incidence [ Time Frame: monthly ]

Secondary Outcome Measures:
  • Scabies-induced skin abscess incidence [ Time Frame: monthly ]
  • Incidence of Lindane prescription and use [ Time Frame: monthly ]
  • Incidence of Ivermectin prescription and use [ Time Frame: monthly ]
  • Scabies disease, treatment, and prevention awareness [ Time Frame: monthly ]

Enrollment: 1057
Study Start Date: May 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ivermectin
Non-pregnant, non-breastfeeding, taller than 90cm and 5 years or older
Drug: Ivermectin
Ivermectin 200ug/kg, 1 dose Q 6 months x 2, total duration = 12 months
Other Name: Ivermectina
Experimental: Permethrin
Pregnant, breastfeeding, children under 90cm or under 5 years old
Drug: Permethrin 5% lotion
apply lotion to entire body, excluding head, at bedtime, rinse off following morning, wait one week, repeat application for a total of 2 applications, PRN frequency, NMT 6 applications in 12 months, total duration = 12 months.
Other Name: Permethrina locion

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

IVERMECTIN ARM:

  • able to swallow pills
  • no known allergy to Ivermectin
  • not pregnant
  • not breastfeeding
  • 5 years or older
  • taller than 90cm
  • willingness to participate in study and give written consent

PERMETHRIN ARM:

  • no known allergy to Permethrin 5% lotion
  • able to apply lotion to self or to other person if a child
  • pregnant
  • breastfeeding
  • younger than 5 years
  • shorter than 90cm
  • willingness to participate in study and give written consent

Exclusion Criteria:

IVERMECTIN ARM:

  • unable to swallow pills
  • allergy to Ivermectin
  • pregnant
  • breastfeeding
  • younger than 5 years
  • shorter than 90cm
  • unwilling to participate in study or give written consent

PERMETHRIN ARM:

  • unable to apply lotion to self
  • allergy to Permethrin 5% lotion
  • not pregnant
  • not breastfeeding
  • 5 years or older
  • taller than 90cm
  • unwilling to participate in study or give written consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00604084


Locations
Dominican Republic
Barrio Nuevo
Veron, La Altagracia, Dominican Republic
Sponsors and Collaborators
Edward Via Virginia College of Osteopathic Medicine
Investigators
Principal Investigator: Jeremy J White, DO Virginia College of Osteopathic Medicine
Study Chair: Dean Sutphin, PhD Virginia College of Osteopathic Medicine
  More Information

Publications:
Responsible Party: Jeremy Jason White, DO, Virginia College of Osteopathic Medicine
ClinicalTrials.gov Identifier: NCT00604084     History of Changes
Other Study ID Numbers: IRB#2007/006
First Submitted: January 16, 2008
First Posted: January 29, 2008
Last Update Posted: March 10, 2009
Last Verified: March 2009

Keywords provided by Edward Via Virginia College of Osteopathic Medicine:
Scabies
Ivermectin
Lindane
Mass Eradication

Additional relevant MeSH terms:
Scabies
Mite Infestations
Ectoparasitic Infestations
Skin Diseases, Parasitic
Parasitic Diseases
Skin Diseases, Infectious
Skin Diseases
Ivermectin
Permethrin
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action