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CompletedNCT00604084VSEEPUpdated Jul 22, 2019

Veron Scabies Education and Eradication Program

An interventional study of Ivermectin and Permethrin 5% lotion in Scabies, sponsored by Edward Via Virginia College of Osteopathic Medicine. Completed at 1 site in Dominican Republic. Per ClinicalTrials.gov, last updated 2019-07-22.

Sponsored by Edward Via Virginia College of Osteopathic Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
1,057
Allocation
Non-randomized
Sex
All
01

Study 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.

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Introduction

The Secretaría de Estado de Salud Pública y Asistencia Social public health clinic in Veron, Dominican Republic continually reports a subjectively high prevalence and incidence of scabies infections among its general patient population without any means of direct measurement, proper intervention, or control, raising concerns that long-term infestation may lead to multiple other secondary medical and environmental problems.

The purpose of this project is to develop a community scabies eradication and education program for the highly endemic areas surrounding the Veron community. It proposes the use of oral Ivermectin as a replacement for topical Lindane, a readily available and prescribed pesticide and environmental toxin that is reportedly banned for all uses in the Dominican Republic as well as over 80 other countries throughout the world (Boffa, Brough, \& Ead, 1995; Davies, Dedhia, Mergade, Banquet, \& Maibach, 1983).

Ivermectin, on the other hand, is a remarkably safe, effective, cost-comparative oral medication with a substantially broader scope of coverage, duration of effectiveness, and ease of delivery and compliance when compared to Lindane, as well as over 20 years of use in global mass eradication campaigns for other parasites on the order of more than 50 million doses to date (Alexander, Bockarie, Kastens, Kazra, \& Alpers, 1998; del Guidice, Chosidow, \& Caumes, 2003; Madan, Jaskiran, Gupta, \& Gupta, 2001).

Specific program goals include: the quantification of community disease prevalence, a statistically significant reduction in both scabies incidence as well as secondary disease sequelae, improved community scabies awareness and prevention abilities, and decreased environmental impact on the Veron area by eliminating the use of Lindane for scabies treatment.

The research is designed to employ a door-to-door survey and treatment campaign in a typical Veron neighborhood aimed at evaluating and treating every member in this target population to create a mass prophylaxis that breaks the parasite-host cycle. Another round of treatment will occur 6 months later, per pharmacologic dosage interval recommendations (del Guidice et al., 2003).

Individual and group scabies education programs will occur at the Veron clinic, as well as at the local schools to target the highly susceptible youth populations throughout the Veron area.

Incidence measurements will occur on a monthly basis for one year after program start, coinciding with two 6-month treatment intervals. At the end of one year, final scabies prevalence and incidence data will be evaluated for statistical significance. While mass treatments will cease at this time, oral Ivermectin will become the standard of care for ectoparasite coverage at the Veron clinic assuming a statistically significant reduction in scabies prevalence is achieved.

To date, no mass scabies eradication programs using oral Ivermectin have been reported in the Caribbean, despite it remarkable success in other countries against scabies as well as other parasites, namely onchocerciasis and filariasis (Walker \& Johnstone, 2000; Walton \& Holt, 2004). This project has the potential to be an important contribution to the effort to eradicate a source of significant morbidity for both the people of Veron and the global community as a whole.

Methodology

The Veron Scabies Eradication and Education Program will obtain all its priority population data via door-to-door interviews within the Barrio Nuevo neighborhood.

A survey team of medical personnel will walk door-to-door program in an attempt to survey and treat every inhabitant of Barrio Nuevo, unless there is refusal or absolute contraindications. Subjects will first be informed of the program and its intent, asked to sign a letter of patient confidentiality, and assigned a number identifier for tracking purposes.

After consent is obtained, a survey will be administered to collect basic demographic information, scabies knowledge indicators, as well as pertinent past and current medical history related to scabies infection and contraindications to treatment with Ivermectin.

The subject will then be asked to undergo a brief skin exam that assesses scabies infectivity and results recorded using the following criteria: the presence of erythematous popular, vesicular, pustular, or bullous lesions associated with itching. Information will be recorded and used to guide treatment protocol.

After the skin exam, subjects will be instructed on scabies medical treatment and prevention, given a patient information and education pamphlet, asked if they have any specific questions or concerns, informed of ongoing community scabies education workshops at the clinic, and instructed to return to the clinic in 2 weeks if they have an active scabies infection. Otherwise, they will be informed that the researchers will return to their neighborhood each month to collect more information and in 6 months to administer another treatment.

Finally, the subject will be given 200μg/kg oral Ivermectin dosed by height if they are male or non-pregnant/non-lactating female, 5 years of age or older, and taller than 90 cm.

If the subject is a female and of childbearing age (still menstruating on a monthly basis), not currently menstruating, not able to show proof of using oral contraceptives (birth control pills) or injectable contraceptives (scheduled Depo Provera), not surgically sterile (hysterectomy or tubal ligation) they will be asked to undergo a rapid urine pregnancy test. If the test is negative they will be given 200μg/kg oral Ivermectin dosed by height.

If the subject is knowingly pregnant or lactating, the rapid pregnancy test is positive, or a child under 5 years and shorter than 90 cm they will be instructed on how to properly use Permethrin 5% lotion and given a 60gm bottle.

This protocol will be followed until every household is visited and treated within Barrio Nuevo at time = 0 and again at time = 6 months.

Investigators will conduct monthly scabies incidence surveys via door-to-door skin checks within Barrio Nuevo looking for current scabies symptomatology and recording results on the form described above.

At the end of one year, final scabies prevalence and incidence data will be evaluated for statistical significance. While mass treatments will cease at this time, oral Ivermectin will become the standard of care for ectoparasite coverage at the Veron clinic assuming a statistically significant reduction in scabies prevalence is achieved.

02

Conditions studied

  • Scabies

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Keywords

  • Scabies
  • Ivermectin
  • Lindane
  • Mass Eradication
03

In context

Scabies

51 studies on the registry are indexed under Scabies; 10 are open to participants now.

This study's enrollment of 1,057 is above the median of 183 across 41 interventional studies indexed under Scabies.

Browse Scabies studies →

Lead sponsor

Edward Via Virginia College of Osteopathic Medicine is the lead sponsor of 24 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
1,057 participants (actual)

Study arms

  • Experimental
    Ivermectin

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

    Drug: Ivermectin

  • Experimental
    Permethrin

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

    Drug: Permethrin 5% lotion

Interventions

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

    Also known as: Ivermectina

  • 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

06

What researchers measure

Primary outcomes

  1. Scabies incidence

    Time frame: monthly

Secondary outcomes

  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

07

Study locations

1 site
  • Barrio Nuevo
    Veron, La Altagracia, Dominican Republic
08

References and documents

Publications

  • 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. PubMed 8547026 ↗
  • 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. PubMed 6186202 ↗
  • 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. PubMed 9861413 ↗
  • del Giudice P, Chosidow O, Caumes E. Ivermectin in dermatology. J Drugs Dermatol. 2003 Jan;2(1):13-21. PubMed 12852376 ↗
  • 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. PubMed 11603388 ↗
  • Walker GJ, Johnstone PW. Interventions for treating scabies. Cochrane Database Syst Rev. 2000;(3):CD000320. doi: 10.1002/14651858.CD000320. PubMed 10908470 ↗
  • 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. PubMed 15504541 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2007, a primary completion of May 2008 and a completion of May 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 16, 2008
First posted
Jan 29, 2008
Start
May 2007
Primary completionActual
May 2008
CompletionActual
May 2008
Last update
Jul 22, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 22, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00604084
Lead sponsor
Edward Via Virginia College of Osteopathic Medicine
Responsible party
Sponsor
First posted
Jan 29, 2008
Start date
May 2007
Primary completion
May 2008
Completion
May 2008
Last update
Jul 22, 2019

Study contacts

Jeremy J White, DO
principal investigator · Virginia College of Osteopathic Medicine
Dean Sutphin, PhD
study chair · Virginia College of Osteopathic Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Ivermectin · Permethrin

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