Better Disease Control by Multidrug Regimen in Scabies

Sponsor

B.P. Koirala Institute of Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT05198947

Collaborator

(none)

212

Enrollment

Arms

17.9

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Scabies	Drug: Permethrin Lotion 5% Drug: Permethrin Lotion 5% and Oral Ivermectin 200 mcg/kg	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

212 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Jul 1, 2018

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Pruritus [1 month]
Rate of relief from pruritus assessed using visual analog scale

Secondary Outcome Measures

Skin lesions [1 month]
Rate of eradication of skin lesions assessed using physician global assessment scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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