| CTRI Number |
CTRI/2025/10/095673 [Registered on: 07/10/2025] Trial Registered Prospectively |
| Last Modified On: |
03/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Comparison of Three Medications for Head Lice: Finding the Safest and Most Effective Option." |
|
Scientific Title of Study
|
Effectiveness and Safety of Spinosad 0.9 percent Topical Solution vs Permethrin 1 percent Topical Solution vs Ivermectin 0.5 percent Topical Lotion in the Treatment of Pediculosis humanus capitis (head lice) Infestation: A Prospective, Comparative, Three arm, Double blind, Randomized Controlled Study |
| 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, Mandya |
| Address |
OPD Number 13, 1st floor, Department of Dermatology, Mandya institute of medical sciences, Mandya 571401
Mandya
KARNATAKA
571401
India |
| Phone |
9844861596 |
| Fax |
|
| Email |
deepadarshan.rani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shashikumar BM |
| Designation |
Associate professor and Head of the department, Department of Dermatology, MIMS ,Mandya |
| Affiliation |
Mandya institute of medical sciences, Mandya |
| Address |
OPD Number 13, 1st floor, Department of Dermatology, Mandya institute of medical
sciences, Mandya 571401
Mandya
KARNATAKA
571401
India |
| Phone |
9886197902 |
| Fax |
|
| Email |
shashikumarbm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shashikumar BM |
| Designation |
Associate professor and Head of the department, Department of Dermatology, MIMS ,Mandya |
| Affiliation |
Mandya institute of medical sciences, Mandya |
| Address |
OPD Number 13, 1st floor, Department of Dermatology, Mandya institute of medical
sciences, Mandya 571401
Mandya
KARNATAKA
571401
India |
| Phone |
9886197902 |
| Fax |
|
| Email |
shashikumarbm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mandya institute of medical sciences, Mandya |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL
|
| Type of Sponsor |
Other [NIL] |
|
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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 |
Department of Dermatology, OPD no 13, 1st floor, Mandya institute of medical sciences, Bangalore Mysore highway, Mandya, Karnataka 571401
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 |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B850||Pediculosis due to Pediculus humanus capitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ivermectin 0.5% lotion (Arm C) |
Intervention Description: Ivermectin 0.5% Topical Lotion is a prescription medication used to treat head lice. It is an anti-parasitic agent that works by paralyzing and killing lice.
Dosage/Administration:
Apply the lotion to dry hair and scalp, ensuring full coverage.
Leave the lotion on for 10 minutes before washing it off.
Frequency: One-time
Formulation: Topical lotion (0.5% concentration).
Route of Administration: Topical.
Treatment Duration: Single application for a duration of 10 minutes.
Rationale for Use: Ivermectin has proven efficacy against head lice, and it is a preferred alternative in cases of resistance to other treatments. It works by paralyzing the lice and inhibiting their survival. |
| Comparator Agent |
Permethrin 1% solution (Arm B) |
Intervention Description: Permethrin 1% Topical Solution is an over-the-counter medication used for the treatment of head lice. It is a synthetic insecticide that targets the nervous system of lice.
Dosage/Administration:
Apply to the scalp and hair, ensuring complete coverage.
Leave it on for 10 minutes before rinsing.
Frequency: Once.
Formulation: Topical solution (1% concentration).
Route of Administration: Topical.
Treatment Duration: Single application for 10 minutes duration.
Rationale for Use: Permethrin is a common first-line treatment for head lice, known for its safety and efficacy in children and adults. It kills lice by disrupting their nervous system. |
| Intervention |
Spinosad 0.9% solution (Arm A) |
Intervention Description: Spinosad 0.9% Topical Solution is a prescription medication used for the treatment of head lice infestation. It contains Spinosad, a naturally derived insecticide, which is applied to the scalp and hair.
Dosage/Administration:
Apply the solution directly to dry hair and scalp, ensuring full coverage.
Leave it on for 10 minutes before rinsing off.
Frequency: Once
Formulation: Topical solution (0.9% concentration).
Route of Administration: Topical.
Treatment Duration:1 application for 10 minutes.
Rationale for Use: Spinosad acts as an insect neurotoxin, killing both lice and their eggs. It is typically well-tolerated and does not require combing, unlike other treatments. |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects must have an active head lice infestation of at least three live lice and/or viable nits. (Viability of nits to be determined by using magnifying lens at a distance of less than 0.6 cm from the scalp).
Following application and rinsing of the test article, subject agrees not to shampoo, wash, or rinse their hair or scalp until the 24 hour post treatment evaluation has been completed.
Subjects agree not to cut or chemically treat their hair while participating in the study.
Subject and/or parent/guardian agree that the subject will not use any other form of lice treatment during the duration of the study.
Subjects who are willing to sign informed consent for participation in the study.
Subjects who are willing to sign informed assent for participation in the study.
|
|
| ExclusionCriteria |
| Details |
Female subjects who are pregnant or lactating or planning to become pregnant during the study period. Females who are not ready to use acceptable contraceptive methods during the course of study.
Scalp condition that could make it difficult to evaluate the extent and severity of an infestation or that would present a problem in the evaluation of response to therapy (e.g. psoriatic scalp lesions, extensive seborrheic dermatitis).
Treatment for head lice (OTC, home remedy and/or prescription drugs) in the last 7 days.
Subject who used any hair dye, bleaches, hair straightening or permanent wave solution on the hair within 14 days of randomization.
Known history of irritation or sensitivity to pediculicides or hair care products.
Subjects with known allergy or hypersensitivity to Spinosad/Permethrin/Ivermectin or any component of the test product.
Subjects who are a known case of epilepsy or any neurological disorder.
Subject receiving any other treatment which may interfere with the study results.
Participation in a previous investigational drug study within the past 30 days.
Does not understand the requirements for study participation and/or may likely exhibit poor compliance |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of subjects within each treatment group who are lice free (without live lice) at the end of study. |
Subjects are assessed on day 1 (baseline) and on day 14 for the presence of live lice. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of subjects within each treatment group who are free from viable nits at the end of study. |
Subjects are assessed on day 1 (baseline) and on day 14 for the presence of viable nits. |
| Proportion of subjects within each treatment group with improvement in Pruritus score at the end of study compared to baseline. |
Pruritis assessment scoring is done at the baseline (day 1) and at the end of the study (day 14)
None =0 The scalp does not itch.
Mild=1 Ocassional episodes of itching, not bothersome.
Moderate=2 Frequent, several times a day, bothersome.
Severe=3 Nearly constant, frequent scratching, very bothersome. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/10/2025 |
| Date of Study Completion (India) |
17/02/2026 |
| 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
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective, comparative, three-arm, double-blind, randomized controlled study designed to assess the effectiveness and safety of three different topical treatments for head lice (Pediculosis humanus capitis) infestation. Subjects with head lice will be randomly assigned in a 1:1:1 ratio to one of three groups: Arm A (Spinosad), Arm B (Permethrin), or Arm C (Ivermectin). The study is double-blind, meaning neither the subjects nor the researchers will know which treatment is being given. On Day 1, a single application of the assigned medication will be applied to the dry hair and scalp, left on for 10 minutes, and then rinsed off. The primary objective is to compare the effectiveness of the three treatments in eradicating head lice infestation. The secondary objective is to evaluate the safety profile of each medication by monitoring for any adverse reactions in the subjects. This study will provide valuable, evidence-based data on the relative efficacy and safety of three common head lice treatments. The findings can help healthcare professionals make more informed decisions when prescribing treatment, especially in regions where resistance to older medications like permethrin is a concern. The results will also contribute to a better understanding of the overall safety of these medications, which is crucial for public health, particularly for children who are the most common sufferers of head lice. |