Better Disease Control by Multidrug Regimen in Scabies

NCT ID: NCT05198947

Last Updated: 2022-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

212 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Scabies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group 1 Permethrin only

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

Group Type ACTIVE_COMPARATOR

Permethrin Lotion 5%

Intervention Type DRUG

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

Group 2 Permethrin and Ivermectin

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

Group Type ACTIVE_COMPARATOR

Permethrin Lotion 5% and Oral Ivermectin 200 mcg/kg

Intervention Type DRUG

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

Interventions

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Permethrin Lotion 5%

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

Intervention Type DRUG

Permethrin Lotion 5% and Oral Ivermectin 200 mcg/kg

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

5 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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B.P. Koirala Institute of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Prajwal Pandey

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Prajwal Pandey, MD

Role: PRINCIPAL_INVESTIGATOR

B.P. Koirala Institute of Health Sciences

Sudha Agrawal, MD

Role: STUDY_DIRECTOR

B.P. Koirala Institute of Health Sciences

References

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

Reference Type BACKGROUND
PMID: 16731272 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24566946 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 19580575 (View on PubMed)

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 23343887 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 17636630 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29608022 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18230034 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30615283 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32484302 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1673175 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1725779 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 21860157 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29241784 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22960817 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22385121 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30544123 (View on PubMed)

Other Identifiers

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162/073/074-IRC

Identifier Type: -

Identifier Source: org_study_id

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