To compare efficacy of topical 5% permethrin versus oral ivermectin in the treatment of scabies
Design
Total sample size 60 patients divided in two groups of 30 patients each. Both intervention groups . Single center , community based , parallel group , randomized controlled trial.
Settings and conduct
Department of Dermatology Pak Emirates Military Hospital, Rawalpindi.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
● Patients above 5 years of age and more than 15 kg of weight
● Both genders
● Patients having scabies as per operational definition
Exclusion Criteria:
● Pt treated with any scabicidal therapy in the last 01 month
● Pts taking any topical or systemic antibiotic therapy in the week before entry into the study
● H/o allergy to any study drugs
● Immunologically-compromised patients
● H/o secondary bacterial infection
● Pregnancy
● Crusted/Norwegian scabies
Intervention groups
After taking permission from ethical committee of hospital 60 Patients with informed consent, fulfilling the inclusion criteria were included in study. Randomization was conducted through sequentially numbered opaque envelopes generated from a random numbered table into two groups of 30 patients each. Each patient was assigned a number at enrollment which defined a study assignment ( topical 5% permethrin versus oral ivermectin).30 patients sample size for 5% permethrin cream group (Group A) while 30 patients sample size for oral ivermectin group (Group B). Permethrin group were asked to apply the cream to whole body covering neck to toe for 12 hrs. Ivermectin grp were given single dose tab ivermectin . Patients were followed up at the end of 1st , 2nd and 4th weeks. Data regarding efficacy from both groups was noted as per operational definition by researcher on especially designed proforma.
Main outcome variables
Pruritus,
Scabietic lesions (papules, burrows)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221222056891N1
Registration date:2023-01-13, 1401/10/23
Registration timing:retrospective
Last update:2023-01-13, 1401/10/23
Update count:0
Registration date
2023-01-13, 1401/10/23
Registrant information
Name
Tahir Rao
Name of organization / entity
Pak Emirates Military Hospital
Country
Pakistan
Phone
+92 333 7637382
Email address
tahir_rao@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-01, 1399/10/12
Expected recruitment end date
2021-06-30, 1400/04/09
Actual recruitment start date
2021-01-01, 1399/10/12
Actual recruitment end date
2021-06-30, 1400/04/09
Trial completion date
2021-06-30, 1400/04/09
Scientific title
Comparison Of Efficacy Of Single Application Topical 5% Permethrin Versus Single Dose Oral Ivermectin In The Treatment Of Scabies
Public title
Permethrin and Ivermectin in the Scabies Treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients above 5 years of age and more than 15 kg of weight
Both genders
Patients having scabies as per operational definition
Exclusion criteria:
Patient treated with any scabicidal therapy in the last 01 month
Patients taking any topical or systemic antibiotic therapy in the week before entry into the study
H/o allergy to any of the study drugs
Immunologically-compromised patients
Pregnancy in women
Crusted/Norwegian scabies
H/o secondary bacterial infection
Age
From 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was conducted through sequentially numbered opaque envelopes generated from a random numbers table into two groups of 30 patients each. Each patient was assigned a number at enrollment which defined a study assignment (Topical 5% Permethrin versus Oral Ivermectin).Method of randomization was simple and unit individual.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee Pak Emirates Military Hospital
Street address
Peshawar road, rawalpindi saddar
City
Rawalpindi
Postal code
46000
Approval date
2020-12-08, 1399/09/18
Ethics committee reference number
A/28/EC/80/2020
Health conditions studied
1
Description of health condition studied
Scabies
ICD-10 code
B86
ICD-10 code description
Scabies
Primary outcomes
1
Description
Pruritus
Timepoint
At the time of treatment and at 1st, 2nd and 4th week after intervention.
Method of measurement
History for pruritus (relieved/not relieved)
2
Description
Scabietic Lesions (Burrows and Papules)
Timepoint
At the time of treatment and at 1st, 2nd and 4th week after intervention
Method of measurement
Clinical Examination and Dermoscopy for scabietic lesions (present/not present)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Permethrin Group(A): 30 patients fulfilling inclusion criteria were prescribed permethrin 5% cream. They were asked to apply the cream to whole body covering neck to toe. After application patient were to wear clothes. They were explained that the cream must remain in contact with the skin for at least 12 hours and not to take bath before 12 hours after application. Patients were asked to take bath after 12 hrs . If any other family member was having similar symptoms he was also prescribed same medication. Patients were evaluated at week 1,2 and 4 after the treatment for resolution of pruritus and scabietic lesions and development of any adverse effects.
Category
Treatment - Drugs
2
Description
Intervention group: Intervention group(B): 30 patients fulfilling inclusion criteria received oral ivermectin 200ug/kg( Tab Ivermite) single dose only and were evaluated at week 1,2 and 4 after the treatment for resolution of pruritus and scabietic lesions and development of any adverse effects.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Pak Emirates Military Hospital
Full name of responsible person
Rao Muhammad Tahir Sattar
Street address
Pedhawar road, Rawalpindi saddar
City
Rawalpindi
Postal code
46000
Phone
+92 333 7637382
Email
tahir_rao@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pak Emirates Military Hospital
Full name of responsible person
Rao Muhammad Tahir Sattar
Street address
Peshawar Road,Rawalpindi saddar
City
Rawalpindi
Postal code
46000
Phone
+92 333 7637382
Email
tahir_rao@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pak Emirates Military Hospital
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Pak Emirates Military Hospital
Full name of responsible person
Tahir Rao
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Flat M, Block D10, CMT and SD Golra , Rawalpindi, Punjab Pakistan
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 333 7637382
Fax
Email
tahir_rao@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pak Emirates Military Hospital
Full name of responsible person
Tahir Rao
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Flat M, Block D10, CMT and SD Golra , Rawalpindi, Punjab Pakistan
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 333 7637382
Fax
Email
tahir_rao@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Pak Emirates Military Hospital
Full name of responsible person
Tahir Rao
Position
Consultant
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Flat M, Block D10, CMT and SD Golra , Rawalpindi, Punjab Pakistan
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 333 7637382
Fax
Email
tahir_rao@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Deidentified Individual participant data like age, weight, duration of disease, gender, given drug and response to treatment will be shared. Efficacy with respect to duration of disease, gender, age and weight will also be provided.
When the data will become available and for how long
Data will be shared after the publication of the article likely by end of 2023.
To whom data/document is available
To the people associated with medical profession.
Under which criteria data/document could be used
Documents would be used for educational purposes and will be shared by mail and will be entertained by primary researcher.
From where data/document is obtainable
Data could be obtained from primary researcher as well as from Department of dermatology pak Emirates Military Hospital.
What processes are involved for a request to access data/document
Data could be obtained by mail and in person from hospital after approval from competent authority.