Better Disease Control by Multidrug Regimen in Scabies

January 5, 2022 updated by: Prajwal Pandey, B.P. Koirala Institute of Health Sciences

Better Disease Control by Multidrug Regimen in Scabies: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

212

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1 Permethrin only
Standard regimen of permethrin 5% topical application to be repeated after 1 week.
Drug: Permethrin Lotion 5%
Topical permethrin 5% lotion to apply on day 1 and repeat after 1 week.
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
Topical permethrin 5% lotion and oral ivermectin 200 mcg/kg to be taken on day 1 only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pruritus
Time Frame: 1 month
Rate of relief from pruritus assessed using visual analog scale
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin lesions
Time Frame: 1 month
Rate of eradication of skin lesions assessed using physician global assessment scale
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

B.P. Koirala Institute of Health Sciences

Investigators

  • Principal Investigator: Prajwal Pandey, MD, BP Koirala Institute of Health Sciences
  • Study Director: Sudha Agrawal, MD, BP Koirala Institute of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

December 17, 2021

First Submitted That Met QC Criteria

January 5, 2022

First Posted (Actual)

January 20, 2022

Study Record Updates

Last Update Posted (Actual)

January 20, 2022

Last Update Submitted That Met QC Criteria

January 5, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 162/073/074-IRC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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