| CTRI Number |
CTRI/2024/11/076913 [Registered on: 18/11/2024] Trial Registered Prospectively |
| Last Modified On: |
12/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the effects of permethrin and ivermectin in patients with scabies. |
|
Scientific Title of Study
|
A Comparative study to evaluate Efficacy and Safety of Topical Permethrin versus Oral Ivermectin in patients with scabies at a tertiary care centre: A Randomised controlled study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anitha |
| Designation |
Postgraduate |
| Affiliation |
Bangalore medical college and research institute bangalore |
| Address |
Department of Pharmacology,Bangalore medical college and research institute,Bangalore
Fort,Krishna rajendra road,Kalasipalya, Bengaluru,Karnataka 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
8867145180 |
| Fax |
|
| Email |
anithasimpi8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrGeetha A |
| Designation |
Proffessor and HOD |
| Affiliation |
Bangalore medical college and research institute bangalore |
| Address |
Department of Pharmacology,Bangalore medical college and research institute,Bangalore
Fort,krishna rajendra road,kalasipalya, Bengaluru,Karnataka 560002
Bangalore
KARNATAKA
560002
India |
| Phone |
9886224085 |
| Fax |
|
| Email |
geethaanantharamaiah@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrGeetha A |
| Designation |
Proffessor and HOD |
| Affiliation |
Bangalore medical college and research institute bangalore |
| Address |
Department of Pharmacology,Bangalore medical college and research institute,Bangalore
Fort,krishna rajendra road,kalasipalya, Bengaluru,Karnataka 560002
KARNATAKA
560002
India |
| Phone |
9886224085 |
| Fax |
|
| Email |
geethaanantharamaiah@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Anitha |
| Address |
Dept of Pharmacology, Bangalore medical college and research institute Bengaluru 560002 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anitha |
Victoria hospital |
Department of Dermatology OPD Block, second floor Victoria hospital Bangalore
Bangalore
KARNATAKA |
8867145180
anithasimpi8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee of BMCRI |
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 |
Permethrin cream |
Two times topical application of five percent permethrin cream once a week |
| Comparator Agent |
Tab Ivermectin |
Tab Ivermectin 12mg oral route 2 tablets once a week. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing to give written informed consent
2. Patients of either sex aged 18 to 60 years
3. Patients diagnosed with uncomplicated scabies |
|
| ExclusionCriteria |
| Details |
1. Patients with crusted scabies, secondary infections and its consequences like skin sores, septicemia, heart disease, chronic kidney disease.
2. Patients with history of epileptic fits, immunodeficiency and any other coexisting skin disease that could interfere with treatment evaluation.
3. Pregnant and lactating mothers
4. In addition, patients with history of known hypersensitivity to Ivermectin.
5. Psychiatric/ emotional disturbance in patients which could limit ability of patients to comply. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Efficacy will be assessed by :
Clinical improvement in signs and symptoms such as,
1.Measuring reduction in the Pruritus with skin rash at week 1 and 2
2.Measuring reduction in skin lesions (change in the size, number and morphology) at week 1 and 2
Safety will be assessed by:
Number and severity of adverse events. |
Efficacy will be assessed by :
Clinical improvement in signs and symptoms such as,
1.Measuring reduction in the Pruritus with skin rash at week 1 and 2
2.Measuring reduction in skin lesions (change in the size, number and morphology) at week 1 and 2
Safety will be assessed by:
Number and severity of adverse events. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="110"
Sample Size from India="110"
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)
|
30/11/2024 |
| 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
|
Need for study: Uncomplicated scabies is a skin disease caused by ectoparasite sarcoptes scabiei var. hominis without crusting, secondary infections and its consequences.It is contagious and most usually seen in congested populations with inadequate cleanliness, spreading swiftly from one person in close touch to another.1 The estimated global prevalence ranges from 0.2 to 71%, affecting over 300 million individuals each year.2 In India, the prevalence ranges from 13% to 59% in both rural and urban areas. Direct contact between individuals occurs when mites crawl on the surface of the skin and develop burrows. Uncomplicated scabies symptoms include itching, skin rashes, and lesions.3 The most common is severe itching, which is usually worse at night. Lesions are slightly elevated brownish tortuous lesions that often appear in the finger webs, flexor surfaces of the wrists, elbows, axillae, buttocks, genitalia, and female breasts.3 Scabies medicines include benzyl benzoate, permethrin ointment, ivermectin cream, lindane, and crotamiton. Ivermectin, taken orally, is the only medicine used to treat ectoparasitosis and is extremely effective against scabies.4 Many people believe that topical permethrin is the medicine of choice right now. For individuals who cannot tolerate or are non-adherent to topical medication, oral Ivermectin is usually preferable. Considering the paucity of comparative studies on efficacy and safety of topical permethrin versus oral ivermectin in uncomplicated scabies amongst Indian patients, this study is being undertaken to compare the therapeutic efficacy and safety of topical permethrin versus oral ivermectin in patients with uncomplicated scabies.3 |