Veron Scabies Education and Eradication Program

NCT00604084 | Completed DMC

• 1 other identifier: IRB#2007/006
• Study Type: interventional
• Target: 1,057
• Locations: 1 country
• Sites: 1

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.

Conditions

Scabies

Keywords

Scabies; Ivermectin; Lindane; Mass Eradication

Outcome Measures

Primary Outcomes (1)

• Scabies incidence

  monthly

Secondary Outcomes (4)

• Scabies-induced skin abscess incidence

  monthly

• Incidence of Lindane prescription and use

  monthly

• Incidence of Ivermectin prescription and use

  monthly

• Scabies disease, treatment, and prevention awareness

  monthly

Study Arms (2)

Ivermectin

EXPERIMENTAL

Non-pregnant, non-breastfeeding, taller than 90cm and 5 years or older

Drug: Ivermectin

Permethrin

EXPERIMENTAL

Pregnant, breastfeeding, children under 90cm or under 5 years old

Drug: Permethrin 5% lotion

Interventions

Ivermectin DRUG

Ivermectin 200ug/kg, 1 dose Q 6 months x 2, total duration = 12 months

Also known as: Ivermectina

Ivermectin

Permethrin 5% lotion DRUG

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.

Also known as: Permethrina locion

Permethrin

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• IVERMECTIN ARM:
• able to swallow pills
• no known allergy to Ivermectin
• not pregnant
• not breastfeeding
• 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

You may not qualify if:

• 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
• years or older
• taller than 90cm

Sponsors & Collaborators

• Edward Via Virginia College of Osteopathic Medicine: lead

Study Sites (1)

Barrio Nuevo

Veron, La Altagracia Province, Dominican Republic

Location

Related Publications (7)

• Boffa MJ, Brough PA, Ead RD. Lindane neurotoxicity. Br J Dermatol. 1995 Dec;133(6):1013. doi: 10.1111/j.1365-2133.1995.tb06950.x. No abstract available.

  PMID: 8547026 BACKGROUND

• Davies JE, Dedhia HV, Morgade C, Barquet A, Maibach HI. Lindane poisonings. Arch Dermatol. 1983 Feb;119(2):142-4. doi: 10.1001/archderm.1983.01650260050017.

  PMID: 6186202 BACKGROUND

• 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. doi: 10.1016/s0035-9203(98)91035-5. No abstract available.

  PMID: 9861413 BACKGROUND

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

  PMID: 12852376 BACKGROUND

• 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. doi: 10.1111/j.1346-8138.2001.tb00015.x.

  PMID: 11603388 BACKGROUND

• Walker GJ, Johnstone PW. Interventions for treating scabies. Cochrane Database Syst Rev. 2000;(3):CD000320. doi: 10.1002/14651858.CD000320.

  PMID: 10908470 BACKGROUND

• Walton SF, Holt DC, Currie BJ, Kemp DJ. Scabies: new future for a neglected disease. Adv Parasitol. 2004;57:309-76. doi: 10.1016/S0065-308X(04)57005-7.

  PMID: 15504541 BACKGROUND

MeSH Terms

Conditions

Scabies

Interventions

Ivermectin; Permethrin

Condition Hierarchy (Ancestors)

Mite Infestations; Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Phenyl Ethers; Ethers; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pyrethrins; Cyclopentane Monoterpenes; Monoterpenes; Terpenes

Study Officials

• Jeremy J White, DO

  Virginia College of Osteopathic Medicine

  PRINCIPAL INVESTIGATOR

• Dean Sutphin, PhD

  Virginia College of Osteopathic Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2008
• First Posted: January 29, 2008
• Study Start: May 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: July 22, 2019

Record last verified: 2019-07

Locations

DO (1)