Veron Scabies Education and Eradication Program (VSEEP)

This study has been completed.
Sponsor:
Information provided by:
Edward Via Virginia College of Osteopathic Medicine
ClinicalTrials.gov Identifier:
NCT00604084
First received: January 16, 2008
Last updated: March 9, 2009
Last verified: March 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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

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

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: January 16, 2008
Last Updated: March 9, 2009
Health Authority: Dominican Republic: Secretaría del Estado de Salud Pública y Asistencia Social (SESPAS)

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
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014