| CTRI Number |
CTRI/2026/01/102014 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of commonly used Ivermectin and Permethrin treatments in patients with scabies |
|
Scientific Title of Study
|
Comparative study of efficacy of Oral Ivermectin, Oral and Topical Ivermectin and Oral Ivermectin with Topical Permethrin in the treatment of scabies |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K Venkateshwaran |
| Designation |
Professor and HOD |
| Affiliation |
Vinayaka Missions Medical College and Hospitals |
| Address |
Department of Dermatology Venereology and Leprosy
Vinayaka Missions Medical College and Hospitals
Keezhakasakudy Medu
Kottucherry Post
Karaikal
Karaikal
PONDICHERRY
609609
India |
| Phone |
9443278353 |
| Fax |
|
| Email |
ksriven@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sakthivel Vaithiyanathan |
| Designation |
Professor and HOD |
| Affiliation |
Vinayaka Missions Medical College and Hospitals |
| Address |
Department of General Medicine
Vinayaka Missions Medical College and Hospitals
Keezhakasakudy Medu
Kottucherry Post
Karaikal
Karaikal
PONDICHERRY
609609
India |
| Phone |
9842426095 |
| Fax |
|
| Email |
generalmedicine@vmmckkl.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Venkateshwaran |
| Designation |
Professor and HOD |
| Affiliation |
Vinayaka Missions Medical College and Hospitals |
| Address |
Department of Dermatology Venereology and Leprosy
Vinayaka Missions Medical College and Hospitals
Keezhakasakudy Medu
Kottucherry Post
Karaikal
Karaikal
PONDICHERRY
609609
India |
| Phone |
9443278353 |
| Fax |
|
| Email |
ksriven@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SELF |
| Address |
Vinayaka Missions Medical College and Hospitals
Keezhakasakudy Medu
Kottucherry Post
Karaikal 609609
Pondicherry
|
| Type of Sponsor |
Other [Individual (Self-sponsored study)] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr K Venkateshwaran |
Vinayaka Missions Medical College and Hospitals
Keezhakasakudy Medu
Kottucherry Post
Karaikal 609609
Pondicherry
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sonavasvini Saravanan |
VINAYAKA MISSIONS MEDICAL COLLEGE AND HOSPITAL |
Department of Dermatology Venereology and Leprosy
VINAYAKA MISSIONS MEDICAL COLLEGE AND HOSPITAL
Keezhakasakudy Medu
Kottucherry post
Karaikal 609609
Karaikal
PONDICHERRY |
9952852512
vasvinisona@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Oral Ivermectin alone
and oral ivermectin with topical ivermectin and topical permethrin |
Group A B and C will be informed to take a stat dose of Oral Ivermectin 200microgram/kg on 1st visit (day 0) and repeat the same on 2nd visit (day 7)
The patients in group B will be advised to apply Ivermectin 1% lotion from neck to whole body at night and must be in contact with the skin at least 8 hours and wash off next morning
The patients in group C will be advised to apply permethrin 5% cream from the neck to all over the body at night and must be in contact with the skin at least 8 hours and wash off next morning
Patients in each groups will be followed every week for 4 weeks |
| Comparator Agent |
Oral Ivermectin alone
Oral Ivermectin + Topical Ivermectin
Oral Ivermectin + Topical Permethrin |
Group A, B and C will be informed to take a stat dose of Oral Ivermectin 200microgram/kg on 1st visit (day 0) and repeat the same on 2nd visit (day 7)
Group B will be advised to apply Ivermectin 1% lotion from neck to whole body at night and must be in contact with the skin at least 8 hours and wash off next morning. Group C will be advised to apply permethrin 5% cream from the neck to all over the body at night and must be in contact with the skin at least 8 hours and wash off next morning. Patients in each groups will be followed every week for 4 weeks |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
New patients of scabies age between 5 to 60 years
History of involvement of family members or similar symptoms in contacts
Patient with history of nocturnal itching
Patients who were willing to participate and give written informed consent |
|
| ExclusionCriteria |
| Details |
Age below 5 years, patients more than 60 years
Pregnant women and lactating women
Patients not willing to participate and for follow-up
Prior use of topical or systemic scabicide in last 4 weeks
Patients on radiotherapy, steroids or other immunosuppressive drugs for any systemic or cutaneous indication
Hypersensitivity to permethrin or ivermectin
Participants with any other associated skin disease, which would alter the picture of scabies |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Complete resolution of active scabetic lesions and
Absence of new lesions |
Two to Four weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in pruritus, time to symptom relief, adverse effects, and recurrence rates |
Two to Four weeks |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/02/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Scabies is a common parasitic infestation treated with oral ivermectin and topical agents. This studies aims to compare the efficacy of oral ivermectin alone, oral ivermectin with topical ivermectin , and oral ivermectin with topical permethrin in patients with scabies to determine the most effective treatment regimen |