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Veron Scabies Education and Eradication Program (VSEEP)

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ClinicalTrials.gov Identifier: NCT00604084
Recruitment Status : Completed
First Posted : January 29, 2008
Last Update Posted : March 10, 2009
Sponsor:
Information provided by:
Edward Via Virginia College of Osteopathic Medicine

Brief Summary:
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 or disease Intervention/treatment Phase
Scabies Drug: Ivermectin Drug: Permethrin 5% lotion Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1057 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Veron Scabies Education and Eradication Program
Study Start Date : May 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scabies

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Scabies incidence [ Time Frame: monthly ]

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


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Ages Eligible for Study:   Child, Adult, Older Adult
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

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

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 Posted: January 29, 2008    Key Record Dates
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