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CompletedNCT05198947Updated Jan 20, 2022

Better Disease Control by Multidrug Regimen in Scabies

An interventional study of Permethrin Lotion 5% and Permethrin Lotion 5% and Oral Ivermectin 200 mcg/kg in Scabies, sponsored by B.P. Koirala Institute of Health Sciences. Completed. Open to participants aged 5 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-01-20.

Sponsored by B.P. Koirala Institute of Health Sciences · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 11 months after the study started (first participant enrolled Jan 2017, registered Dec 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
212
Allocation
Randomized
Ages
5 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Scabies

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Keywords

  • Scabies
  • Permethrin
  • Ivermectin
  • Combination Regimen
03

In context

Scabies

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

This study's enrollment of 212 is above the median of 183 across 41 interventional studies indexed under Scabies.

Browse Scabies studies →

Lead sponsor

B.P. Koirala Institute of Health Sciences is the lead sponsor of 54 studies on the registry; 6 are open to participants now.

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

04

Who can participate

Ages eligible
5 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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

Exclusion criteria

Exclusion Criteria:

  • Unwilling patients
  • Patients with severe co-morbidities requiring long term medication
  • Pregnant women
  • Patients who don't fulfill the age limit criteria
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
212 participants (actual)

Study arms

  • Active comparator
    Group 1 Permethrin only

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

    Drug: Permethrin Lotion 5%

  • Active comparator
    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

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

Interventions

  • DrugPermethrin Lotion 5%

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

  • DrugPermethrin 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.

06

What researchers measure

Primary outcomes

  1. Pruritus

    Rate of relief from pruritus assessed using visual analog scale

    Time frame: 1 month

Secondary outcomes

  1. Skin lesions

    Rate of eradication of skin lesions assessed using physician global assessment scale

    Time frame: 1 month

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Heukelbach J, Feldmeier H. Scabies. Lancet. 2006 May 27;367(9524):1767-74. doi: 10.1016/S0140-6736(06)68772-2. PubMed 16731272 ↗
  • 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. PubMed 24566946 ↗
  • Hicks MI, Elston DM. Scabies. Dermatol Ther. 2009 Jul-Aug;22(4):279-92. doi: 10.1111/j.1529-8019.2009.01243.x. PubMed 19580575 ↗
  • Trettin B, Lassen JA, Andersen F, Agerskov H. The journey of having scabies-a qualitative study. J Nurs Educ Pract. 2018;9(2):1.
  • 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. PubMed 23343887 ↗
  • Strong M, Johnstone P. Interventions for treating scabies. Cochrane Database Syst Rev. 2007 Jul 18;2007(3):CD000320. doi: 10.1002/14651858.CD000320.pub2. PubMed 17636630 ↗
  • 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. PubMed 29608022 ↗
  • 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. PubMed 18230034 ↗
  • 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. PubMed 30615283 ↗
  • 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. PubMed 32484302 ↗
  • 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. PubMed 1673175 ↗
  • 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. PubMed 1725779 ↗
  • 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.
  • 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. PubMed 21860157 ↗
  • 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. PubMed 29241784 ↗
  • 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. PubMed 22960817 ↗
  • 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. PubMed 22385121 ↗
  • 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. PubMed 30544123 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05198947
Lead sponsor
B.P. Koirala Institute of Health Sciences
Responsible party
Prajwal Pandey (Assistant Professor, B.P. Koirala Institute of Health Sciences) — Principal investigator
First posted
Jan 20, 2022
Start date
Jan 2017
Primary completion
Dec 2017
Completion
Jul 2018
Last update
Jan 20, 2022

Study contacts

Prajwal Pandey, MD
principal investigator · B.P. Koirala Institute of Health Sciences
Sudha Agrawal, MD
study director · B.P. Koirala Institute of Health Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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