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Sponsored by: |
Edward Via Virginia College of Osteopathic Medicine |
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Information provided by: | Edward Via Virginia College of Osteopathic Medicine |
ClinicalTrials.gov Identifier: | NCT00604084 |
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 |
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Scabies |
Drug: Ivermectin Drug: Permethrin 5% lotion |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Veron Scabies Education and Eradication Program |
Estimated Enrollment: | 1000 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | May 2008 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Ivermectin: Experimental
Non-pregnant, non-breastfeeding, taller than 90cm and 5 years or older
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Drug: Ivermectin
Ivermectin 200ug/kg, 1 dose Q 6 months x 2, total duration = 12 months
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Permethrin: Experimental
Pregnant, breastfeeding, children under 90cm or under 5 years old
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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.
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Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jeremy J White, DO | 540.250.6402 | jeremyjason@gmail.com |
Contact: Dean Sutphin, PhD | 540.250.2092 | dsutphin@vcom.vt.edu |
Dominican Republic, La Altagracia | |
Barrio Nuevo | Recruiting |
Veron, La Altagracia, Dominican Republic | |
Contact: Jeremy J White, DO 540.250.6402 jeremyjason@gmail.com | |
Contact: Norberto Rojas, MD 809.917.6363 | |
Principal Investigator: Jeremy J White, DO |
Principal Investigator: | Jeremy J White, DO | Virginia College of Osteopathic Medicine |
Study Chair: | Dean Sutphin, PhD | Virginia College of Osteopathic Medicine |
Responsible Party: | Virginia College of Osteopathic Medicine ( Jeremy Jason White, DO ) |
Study ID Numbers: | IRB#2007/006 |
Study First Received: | January 16, 2008 |
Last Updated: | January 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00604084 |
Health Authority: | Dominican Republic: Secretaría del Estado de Salud Pública y Asistencia Social (SESPAS) |
Scabies Ivermectin Lindane Mass Eradication |
Skin Diseases, Infectious Skin Diseases Ivermectin |
Scabies Permethrin Parasitic Diseases |
Anti-Infective Agents Ectoparasitic Infestations Antiparasitic Agents Molecular Mechanisms of Pharmacological Action Skin Diseases, Parasitic |
Therapeutic Uses Enzyme Inhibitors Pharmacologic Actions Mite Infestations |