Veron Scabies Education and Eradication Program - Full Text View

Sponsored by:	Edward Via Virginia College of Osteopathic Medicine
Information provided by:	Edward Via Virginia College of Osteopathic Medicine
ClinicalTrials.gov Identifier:	NCT00604084

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:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Veron Scabies Education and Eradication Program

Resource links provided by NLM:

MedlinePlus related topics: Scabies

Drug Information available for: Permethrin Ivermectin

U.S. FDA Resources

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
Ivermectin: Experimental 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
Permethrin: Experimental 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.

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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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00604084

Locations

Dominican Republic, La Altagracia
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:

Boffa MJ, Brough PA, Ead RD. Lindane neurotoxicity. Br J Dermatol. 1995 Dec;133(6):1013. No abstract available.

Davies JE, Dedhia HV, Morgade C, Barquet A, Maibach HI. Lindane poisonings. Arch Dermatol. 1983 Feb;119(2):142-4.

Alexander ND, Bockarie MJ, Kastens WA, Kazura JW, Alpers MP. Absence of ivermectin-associated excess deaths. Trans R Soc Trop Med Hyg. 1998 May-Jun;92(3):342. No abstract available.

del Giudice P, Chosidow O, Caumes E. Ivermectin in dermatology. J Drugs Dermatol. 2003 Jan;2(1):13-21. Review.

Madan V, Jaskiran K, Gupta U, Gupta DK. Oral ivermectin in scabies patients: a comparison with 1% topical lindane lotion. J Dermatol. 2001 Sep;28(9):481-4.

Walker GJ, Johnstone PW. Interventions for treating scabies. Cochrane Database Syst Rev. 2000;(3):CD000320. Review. Update in: Cochrane Database Syst Rev. 2007;(3):CD000320.

Walton SF, Holt DC, Currie BJ, Kemp DJ. Scabies: new future for a neglected disease. Adv Parasitol. 2004;57:309-76. Review.

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:	March 9, 2009
ClinicalTrials.gov Identifier:	NCT00604084 History of Changes
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

Study placed in the following topic categories:

Anti-Infective Agents
Skin Diseases, Infectious
Skin Diseases
Ivermectin

Scabies
Permethrin
Parasitic Diseases

Additional relevant MeSH terms:

Ectoparasitic Infestations
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Skin Diseases, Parasitic
Skin Diseases
Scabies
Permethrin
Enzyme Inhibitors

Mite Infestations
Pharmacologic Actions
Skin Diseases, Infectious
Antiparasitic Agents
Ivermectin
Therapeutic Uses
Parasitic Diseases

ClinicalTrials.gov processed this record on September 10, 2009