| CTRI Number |
CTRI/2025/11/097926 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
24/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A STUDY ON EFFICACY, SAFETY AND TOLERABILITY OF TOPICAL PERMETHRIN VS TOPICAL SPINOSAD IN MANAGEMENT OF SCABIES |
|
Scientific Title of Study
|
A PROSPECTIVE, RANDOMIZED, OPEN LABEL STUDY ON EFFICACY, SAFETY AND TOLERABILITY OF TOPICAL PERMETHRIN 5 PERCENTAGE VS TOPICAL SPINOSAD 0.9 PERCENTAGE IN MANAGEMENT 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 |
DrNoorain Hamid Khan |
| Designation |
Junior Resident |
| Affiliation |
Shri Bhausaheb Hire Government Medical College |
| Address |
OPD Number 18 ,Department of Dermatology, Venereology and Leprology ,Shri Bhausaheb Hire Government Medical College, Chakkarbardi, Surat bypass, Dhule, 424001
Dhule
MAHARASHTRA
424001
India |
| Phone |
9011933104 |
| Fax |
|
| Email |
noorainkhan18136@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrChetan D. Rajput |
| Designation |
Professor and Head |
| Affiliation |
Shri Bhausaheb Hire Government Medical College |
| Address |
OPD Number 18,Department of Dermatology, Venereology and Leprology Shri Bhausaheb Hire Government Medical College, Chakkarbardi, Surat bypass, Dhule, 424001
Dhule
MAHARASHTRA
424001
India |
| Phone |
8888487808 |
| Fax |
|
| Email |
drchetanrajput@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DrNoorain Hamid Khan |
| Designation |
Junior Resident |
| Affiliation |
Shri Bhausaheb Hire Government Medical College |
| Address |
OPD Number 18, Department of Dermatology, Venereology and Leprology, Shri Bhausaheb Hire Government Medical College, Chakkarbardi, Surat bypass, Dhule, 424001
Dhule
MAHARASHTRA
424001
India |
| Phone |
9011933104 |
| Fax |
|
| Email |
noorainkhan18136@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Bhausaheb Hire Government Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Dr.Noorain Hamid Khan |
| Address |
Pg Hostel,Shri Bhausaheb Hire Government Medical College, Chakkarbardi, Surat bypass, Dhule, 424001 |
| 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 |
| DrNoorain Hamid Khan |
Shri Bhausaheb Hire Government Medical College |
OPD No 18 ,Shri Bhausaheb Hire Government Medical College, Chakkarbardi, Surat bypass, Dhule, 424001
Dhule
MAHARASHTRA |
9011933104
noorainkhan18136@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee SBH,GMC,Dhule |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B86||Scabies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Topical permethrin 5% |
Topical permethrin 5% applied weekly for two weeks |
| Comparator Agent |
Topical Spinosad 0.9% |
Topical spinosad 0.9% weekly for one week |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are clinically diagnosed case of scabies.
Household contacts of the patients.
Age include Above 4 years and less than 65 years.
Both sexes.
Complaint of nocturnal pruritus and papules or excoriation marks over the body.
Patient having typical burrows over the web spaces and involvement of flexures of upper limb, axilla, breast, and groins.
|
|
| ExclusionCriteria |
| Details |
Age less than 4 years, pregnancy, those females planning for pregnancy in next one month and lactation.
Atypical variant and scabies with secondary infection.
H/O recent live vaccination, other scabicide drugs taken in recent past.
Patients with anemia, liver diseases, kidney disease.
Patients with malignancies or lymphoproliferative disorders.
Patients on potent immunosuppresants, immunocompromised individuals.
Family history of melanoma or non melanoma skin cancers.
Patients unwilling to participate in the study.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the clinical efficacy of topical permethrin 5% vs topical spinosad 0.9% in management of scabies |
Baseline, Week One, Week Two, Week Four, Week six |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the safety and tolerability of topical permethrin 5% vs topical spinosad 0.9% in management of scabies |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
01/01/2026 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response (Others) -
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response (Others) -
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 01-01-2026 and end date provided 26-09-2027?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
Brief Summary
Modification(s)
|
Scabies is a contagious parasitic infestation of the skin caused by the itch mite Sarcoptes scabiei var.hominis. There are various treatment options available. This is a prospective, randomized open label clinical study to assess the efficacy, safety, and tolerability of topical permethrin 5% vs topical Spinosad 0.9% in the management of scabies. Each group will have 48 patients each. Group A will include patients who will be treated with topical permethrin 5% lotion applied locally 8 hours overnight from the neck down, followed by shower the next morning and then repeat in 1 week. Group B will include patients who will be treated with topical Spinosad 0.9% lotion applied locally 8 hours overnight from the neck down followed by shower the next morning. Both the groups will be followed up for 4 more weeks thus total duration will be of 6 weeks. Thus the study aims to find the best possible results in management of scabies. |