NCT05198947

Brief Summary

Scabies is associated with significant discomfort and social taboo. Existing treatment regimen frequently fails due to lack of patient compliance. We compared single use regimen to existing standard repeat application regimen for treatment of scabies.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
212

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
Last Updated

January 20, 2022

Status Verified

January 1, 2022

Enrollment Period

11 months

First QC Date

December 17, 2021

Last Update Submit

January 5, 2022

Conditions

Scabies

Keywords

ScabiesPermethrinIvermectinCombination Regimen

Outcome Measures

Primary Outcomes (1)

  • Pruritus

    Rate of relief from pruritus assessed using visual analog scale

    1 month

Secondary Outcomes (1)

  • Skin lesions

    1 month

Study Arms (2)

Group 1 Permethrin only

ACTIVE COMPARATOR

Standard regimen of permethrin 5% topical application to be repeated after 1 week.

Drug: Permethrin Lotion 5%

Group 2 Permethrin and Ivermectin

ACTIVE COMPARATOR

A combination regimen of permethrin 5% topical application with oral ivermectin 200 mcg/kg given on the single day only

Drug: Permethrin Lotion 5% and Oral Ivermectin 200 mcg/kg

Interventions

Permethrin Lotion 5%DRUG

Topical permethrin 5% lotion to apply on day 1 and repeat after 1 week.

Group 1 Permethrin only
Permethrin Lotion 5% and Oral Ivermectin 200 mcg/kgDRUG

Topical permethrin 5% lotion and oral ivermectin 200 mcg/kg to be taken on day 1 only.

Group 2 Permethrin and Ivermectin

Eligibility Criteria

Age5 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Willing patients
  • Clinical diagnosis of scabies
  • Within the age limits

You may not qualify if:

  • Unwilling patients
  • Patients with severe co-morbidities requiring long term medication
  • Pregnant women
  • Patients who don't fulfill the age limit criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (18)

  • Heukelbach J, Feldmeier H. Scabies. Lancet. 2006 May 27;367(9524):1767-74. doi: 10.1016/S0140-6736(06)68772-2.

    PMID: 16731272BACKGROUND

  • FitzGerald D, Grainger RJ, Reid A. Interventions for preventing the spread of infestation in close contacts of people with scabies. Cochrane Database Syst Rev. 2014 Feb 24;2014(2):CD009943. doi: 10.1002/14651858.CD009943.pub2.

    PMID: 24566946BACKGROUND

  • Hicks MI, Elston DM. Scabies. Dermatol Ther. 2009 Jul-Aug;22(4):279-92. doi: 10.1111/j.1529-8019.2009.01243.x.

    PMID: 19580575BACKGROUND

  • Trettin B, Lassen JA, Andersen F, Agerskov H. The journey of having scabies-a qualitative study. J Nurs Educ Pract. 2018;9(2):1.

    BACKGROUND

  • Heukelbach J, Mazigo HD, Ugbomoiko US. Impact of scabies in resource-poor communities. Curr Opin Infect Dis. 2013 Apr;26(2):127-32. doi: 10.1097/QCO.0b013e32835e847b.

    PMID: 23343887BACKGROUND

  • Strong M, Johnstone P. Interventions for treating scabies. Cochrane Database Syst Rev. 2007 Jul 18;2007(3):CD000320. doi: 10.1002/14651858.CD000320.pub2.

    PMID: 17636630BACKGROUND

  • Rosumeck S, Nast A, Dressler C. Ivermectin and permethrin for treating scabies. Cochrane Database Syst Rev. 2018 Apr 2;4(4):CD012994. doi: 10.1002/14651858.CD012994.

    PMID: 29608022BACKGROUND

  • Mounsey KE, Holt DC, McCarthy J, Currie BJ, Walton SF. Scabies: molecular perspectives and therapeutic implications in the face of emerging drug resistance. Future Microbiol. 2008 Feb;3(1):57-66. doi: 10.2217/17460913.3.1.57.

    PMID: 18230034BACKGROUND

  • Sunderkotter C, Aebischer A, Neufeld M, Loser C, Kreuter A, Bialek R, Hamm H, Feldmeier H. Zunahme von Skabies in Deutschland und Entwicklung resistenter Kratzemilben? Evidenz und Konsequenz. J Dtsch Dermatol Ges. 2019 Jan;17(1):15-24. doi: 10.1111/ddg.13706_g. No abstract available.

    PMID: 30615283BACKGROUND

  • Arora P, Rudnicka L, Sar-Pomian M, Wollina U, Jafferany M, Lotti T, Sadoughifar R, Sitkowska Z, Goldust M. Scabies: A comprehensive review and current perspectives. Dermatol Ther. 2020 Jul;33(4):e13746. doi: 10.1111/dth.13746. Epub 2020 Jul 6.

    PMID: 32484302BACKGROUND

  • Taplin D, Porcelain SL, Meinking TL, Athey RL, Chen JA, Castillero PM, Sanchez R. Community control of scabies: a model based on use of permethrin cream. Lancet. 1991 Apr 27;337(8748):1016-8. doi: 10.1016/0140-6736(91)92669-s.

    PMID: 1673175BACKGROUND

  • Purvis RS, Tyring SK. An outbreak of lindane-resistant scabies treated successfully with permethrin 5% cream. J Am Acad Dermatol. 1991 Dec;25(6 Pt 1):1015-6. doi: 10.1016/0190-9622(91)70300-q.

    PMID: 1725779BACKGROUND

  • 1. Mushtaq A, Khurshid K, Pal SS. Comparison of efficacy and safety of oral ivermectin with topical permethrin in treatment of scabies. J Pakistan Assoc Dermatologists. 2010;20(4):227-31.

    BACKGROUND

  • Sharma R, Singal A. Topical permethrin and oral ivermectin in the management of scabies: a prospective, randomized, double blind, controlled study. Indian J Dermatol Venereol Leprol. 2011 Sep-Oct;77(5):581-6. doi: 10.4103/0378-6323.84063.

    PMID: 21860157BACKGROUND

  • Dhana A, Yen H, Okhovat JP, Cho E, Keum N, Khumalo NP. Ivermectin versus permethrin in the treatment of scabies: A systematic review and meta-analysis of randomized controlled trials. J Am Acad Dermatol. 2018 Jan;78(1):194-198. doi: 10.1016/j.jaad.2017.09.006. No abstract available.

    PMID: 29241784BACKGROUND

  • Chhaiya SB, Patel VJ, Dave JN, Mehta DS, Shah HA. Comparative efficacy and safety of topical permethrin, topical ivermectin, and oral ivermectin in patients of uncomplicated scabies. Indian J Dermatol Venereol Leprol. 2012 Sep-Oct;78(5):605-10. doi: 10.4103/0378-6323.100571.

    PMID: 22960817BACKGROUND

  • Goldust M, Rezaee E, Hemayat S. Treatment of scabies: Comparison of permethrin 5% versus ivermectin. J Dermatol. 2012 Jun;39(6):545-7. doi: 10.1111/j.1346-8138.2011.01481.x. Epub 2012 Mar 5.

    PMID: 22385121BACKGROUND

  • Chandler DJ, Fuller LC. A Review of Scabies: An Infestation More than Skin Deep. Dermatology. 2019;235(2):79-90. doi: 10.1159/000495290. Epub 2018 Dec 13.

    PMID: 30544123BACKGROUND

MeSH Terms

Conditions

Scabies

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Mite InfestationsEctoparasitic InfestationsSkin Diseases, ParasiticParasitic DiseasesInfectionsSkin Diseases, InfectiousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Prajwal Pandey, MD

    B.P. Koirala Institute of Health Sciences

    PRINCIPAL INVESTIGATOR

  • Sudha Agrawal, MD

    B.P. Koirala Institute of Health Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 17, 2021

First Posted

January 20, 2022

Study Start

January 1, 2017

Primary Completion

December 1, 2017

Study Completion

July 1, 2018

Last Updated

January 20, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share