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Better Disease Control by Multidrug Regimen in Scabies

Primary Purpose

Scabies

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Permethrin Lotion 5%
Permethrin Lotion 5% and Oral Ivermectin 200 mcg/kg
Sponsored by
B.P. Koirala Institute of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scabies focused on measuring Scabies, Permethrin, Ivermectin, Combination Regimen

Eligibility Criteria

5 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Group 1 Permethrin only

    Group 2 Permethrin and Ivermectin

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Pruritus
    Rate of relief from pruritus assessed using visual analog scale

    Secondary Outcome Measures

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

    Full Information

    First Posted
    December 17, 2021
    Last Updated
    January 5, 2022
    Sponsor
    B.P. Koirala Institute of Health Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05198947
    Brief Title
    Better Disease Control by Multidrug Regimen in Scabies
    Official Title
    Better Disease Control by Multidrug Regimen in Scabies: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2017 (Actual)
    Primary Completion Date
    December 2017 (Actual)
    Study Completion Date
    July 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    B.P. Koirala Institute of Health Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Scabies
    Keywords
    Scabies, Permethrin, Ivermectin, Combination Regimen

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    212 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1 Permethrin only
    Arm Type
    Active Comparator
    Arm Description
    Standard regimen of permethrin 5% topical application to be repeated after 1 week.
    Arm Title
    Group 2 Permethrin and Ivermectin
    Arm Type
    Active Comparator
    Arm Description
    A combination regimen of permethrin 5% topical application with oral ivermectin 200 mcg/kg given on the single day only
    Intervention Type
    Drug
    Intervention Name(s)
    Permethrin Lotion 5%
    Intervention Description
    Topical permethrin 5% lotion to apply on day 1 and repeat after 1 week.
    Intervention Type
    Drug
    Intervention Name(s)
    Permethrin Lotion 5% and Oral Ivermectin 200 mcg/kg
    Intervention Description
    Topical permethrin 5% lotion and oral ivermectin 200 mcg/kg to be taken on day 1 only.
    Primary Outcome Measure Information:
    Title
    Pruritus
    Description
    Rate of relief from pruritus assessed using visual analog scale
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    Skin lesions
    Description
    Rate of eradication of skin lesions assessed using physician global assessment scale
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Prajwal Pandey, MD
    Organizational Affiliation
    BP Koirala Institute of Health Sciences
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Sudha Agrawal, MD
    Organizational Affiliation
    BP Koirala Institute of Health Sciences
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    16731272
    Citation
    Heukelbach J, Feldmeier H. Scabies. Lancet. 2006 May 27;367(9524):1767-74. doi: 10.1016/S0140-6736(06)68772-2.
    Results Reference
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    PubMed Identifier
    24566946
    Citation
    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;(2):CD009943. doi: 10.1002/14651858.CD009943.pub2.
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    PubMed Identifier
    19580575
    Citation
    Hicks MI, Elston DM. Scabies. Dermatol Ther. 2009 Jul-Aug;22(4):279-92. doi: 10.1111/j.1529-8019.2009.01243.x.
    Results Reference
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    Citation
    Trettin B, Lassen JA, Andersen F, Agerskov H. The journey of having scabies-a qualitative study. J Nurs Educ Pract. 2018;9(2):1.
    Results Reference
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    PubMed Identifier
    23343887
    Citation
    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.
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    PubMed Identifier
    17636630
    Citation
    Strong M, Johnstone P. Interventions for treating scabies. Cochrane Database Syst Rev. 2007 Jul 18;2007(3):CD000320. doi: 10.1002/14651858.CD000320.pub2.
    Results Reference
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    PubMed Identifier
    29608022
    Citation
    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.
    Results Reference
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    PubMed Identifier
    18230034
    Citation
    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.
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    PubMed Identifier
    30615283
    Citation
    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.
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    PubMed Identifier
    32484302
    Citation
    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.
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    PubMed Identifier
    1673175
    Citation
    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.
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    PubMed Identifier
    1725779
    Citation
    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.
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    Citation
    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.
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    PubMed Identifier
    21860157
    Citation
    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.
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    29241784
    Citation
    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.
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    Citation
    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.
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    Better Disease Control by Multidrug Regimen in Scabies

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