| CTRI Number |
CTRI/2025/10/095795 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To know the Effectiveness and Safety of Topical Solutions in the Treatment of Scabies. |
|
Scientific Title of Study
|
Effectiveness and Safety of Spinosad 0.9 Percent Topical Solution vs Permethrin 5 Percent Topical Solution in the Treatment of Scabies: A Prospective, Comparative, Two arm, Double blind, Randomized Controlled Study at a Tertiary Care Centre in Mandya. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Deepadarshan K |
| Designation |
Assistant Professor |
| Affiliation |
Mandya Institute Of Medical Sciences |
| Address |
OPD Number 13, 1st Floor, Department of Dermatology, Mandya Institute of Medical Sciences, Mandya
Mandya
KARNATAKA
571401
India |
| Phone |
9844861596 |
| Fax |
|
| Email |
deepadarshan.rani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shashi Kumar B M |
| Designation |
Associate professor and Head of the department |
| Affiliation |
Mandya Institute Of Medical Sciences |
| Address |
OPD Number 13, 1st floor, Department of Dermatology, Mandya Institute of Medical Sciences, Mandya
Mandya
KARNATAKA
571401
India |
| Phone |
9886197902 |
| Fax |
|
| Email |
shashikumarbm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shashi Kumar B M |
| Designation |
Associate Professor and Head of the Department. |
| Affiliation |
MANDYA INSTITUTE OF MEDICAL SCIENCES |
| Address |
OPD Number 13, 1st floor, Department of Dermatology, Mandya Institute of Medical Sciences, Mandya.
Mandya
KARNATAKA
571401
India |
| Phone |
9886197902 |
| Fax |
|
| Email |
shashikumarbm@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD Number 13, Department of Dermatology, Mandya Institute of Medical Sciences, Bengaluru Mysore Road, Mandya, Karnataka, India-571401 |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 Deepadarshan K |
MANDYA INSTITUTE OF MEDICAL SCIENCES |
OPD Number 13, 1st floor, Department of Dermatology, Mandya institute of medical sciences, Mandya
Mandya
KARNATAKA |
09844861596
deepadarshan.rani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee, MIMS, Mandya |
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 |
| Comparator Agent |
PERMETHRIN 5% TOPICAL SOLUTION IN SCABIES |
Permethrin 1% Topical Solution is an over-the-counter medication used for the treatment of scabies. It is a synthetic insecticide that targets the nervous system of lice. Dosage/Administration: Single application over the entire body below the neck to the toes, including soles, and to scalp/hairline, temples, and forehead if balding.
Application done at home on the same day. Frequency: Once. Formulation: Topical solution (5% concentration). Route of Administration: Topical. Treatment Duration: Single application for 8 hours duration. Rationale for Use: Permethrin is a common first-line treatment for scabies, known for its safety and efficacy in children and adults. It is well tolerated. |
| Intervention |
SPINOSAD 0.9% TOPICAL SOLUTION IN SCABIES |
Spinosad 0.9% Topical Solution is a prescription medication used for the treatment of scabies. It contains Spinosad, a naturally derived insecticide. Dosage/Administration: Single application over the entire body below the neck to the toes, including soles, and to scalp/hairline, temples, and forehead if balding. Formulation: Topical solution (0.9% concentration). Route of Administration: Topical. Treatment Duration: one application for 8 hours. Rationale for Use: Spinosad acts as an insect neurotoxin, killing mite. It is well-tolerated. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 5 years or older, either gender with active scabies infestation showing the presence of scabies inflammatory lesions (papules, pustules, vesicles, excoriations), pruritus and confirmed with burrows or mite or eggs in dermatoscopy.
Patient (or their legal guardians) are willing to give the informed consent/ assent to participate in the study
|
|
| ExclusionCriteria |
| Details |
Pretreatment with topical or oral scabicide in the previous 4 weeks.
Use of topical steroids or topical immunosuppressives within 2 weeks.
Patients with special forms of scabies like nodular, crusted scabies.
Patients having scabies with secondary infection or eczematization and coexisting dermatological disease that could interfere with the diagnosis and subsequent monitoring of scabies.
Patients with immunodeficiency or severe systemic disease.
Pregnant, planning for pregnancy during the study and lactating females.
Patients with known hypersensitivity to the drugs.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of subjects within each treatment group showing complete clinical cure defined as reduction in both the number of lesions as well as the grade of pruritus by more than or equal to 50% and negative dermatoscopy. |
Dat 14 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Proportion of patients showing reduced number of lesions/ symptoms.
Proportion of patients showing recurrence of lesions
Proportion of patients with persistence of lesions/symptoms
Dermatology Life Quality Index
|
Day 14
Day 28
Day 14
Day 14 |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/10/2025 |
| Date of Study Completion (India) |
15/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [deepadarshan.rani@gmail.com].
- For how long will this data be available start date provided 01-06-2026 and end date provided 01-06-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
This study is a prospective, double-blind, randomized controlled trial comparing Spinosad 0.9% topical solution and Permethrin 5% cream in the treatment of scabies. A total of 60 patients with clinically and dermatoscopically confirmed scabies will be enrolled and randomly allocated into two groups. Each participant will receive a single application of either Spinosad or Permethrin, with follow-up assessments at 1, 2, and 4 weeks. Effectiveness will be measured by reduction in lesions, pruritus severity, and dermatoscopic cure, while safety will be monitored through adverse events. The primary objective is to compare complete clinical cure rates between the two drugs. The findings aim to provide evidence on whether Spinosad can serve as an effective and safe alternative to Permethrin in routine scabies management. |