ScabiesPhase 2not existedNCT06896929
Comparison of Permethrin and Ivermectin in Children Greater Than 6 Yrs Age for Treatment of Scabies
A Phase 2 study testing Permethrin Cream, 5% and Ivermectin 200 µg/kg in people with Scabies, run by Children Hospital and Institute of Child Health, Lahore at 1 site in Pakistan.
Trial summary
Scabies is highly contagious,pruritic infestation of skin.Various treatment modalities have been used but search for ideal scabicide is ongoing.we wnt to coduct this study to compare the outcome of permethrin verses ivermectin in children for treatment of scabies .This randomized clinical trial will be done in… Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Scabies
- What is being tested?
- Permethrin Cream, 5% and Ivermectin 200 µg/kg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2025to 1 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6-15
- Both genders
- Diagnosed with scabies (as per operational definition)
Who cannot join
- Children with recurrent scabies on medical record
- Known allergy to ivermectin or permethrin.
- Widespread eczema or impetigo.
- Liver dysfunction or renal failure
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Children Hospital Lahore
Lahore, Punjab Province
Sadaf Wazir, MBBs
About this study
Official title: Comparison of Topical Permethrin 1 Day Verses 2 Day Application Versus Oral Ivermectin for Treatment of Scabies in Children Greater Than 6 Yrs of Age
Scabies is highly contagious,pruritic infestation of skin.Various treatment modalities have been used but search for ideal scabicide is ongoing.we wnt to coduct this study to compare the outcome of permethrin verses ivermectin in children for treatment of scabies .This randomized clinical trial will be done in children hospital lahore for 12 months.Sample size of 90 cases;30 in each group will be included through non probability consecutive sampling.Then patient will be randomly divided into 3 groups.In group A patient will be given 5% permethrin topical application to whole body single application. In Group B ,patients will be given topical permethrin for twice application 24 hrs appart ,In group C patients will be given Tablet Ivermectin single dose 200microgram/kg.Then patients will be examined after 2 weeks and 4 weeks for no of lesions and pruritis and cure will be labeled.All this information will be recorded on performa .Data will be entered and analysed by using SPSS version 26.Three groups will be compared for cure by using chi-square test.P value less than and equal to 0.05 will be considered as significant.
- Conditions
- Scabies
- Being tested
- Permethrin Cream, 5%, Ivermectin 200 µg/kg
- Keywords
- Comparison of permethrin and ivermectin in scabies
- Medical subject headings
- Scabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Permethrin Cream, 5%Drug
Permethrin 5% cream will be given as a single application
Permethrin Cream, 5%Drug
Permethrin Cream will be given as twice application
Ivermectin 200 µg/kgDrug
Group C will be given Tab Ivermectin
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Group A will be given Permethrin Receives: Drug: Permethrin Cream, 5% |
| Group B | Experimental | Group B will be given Permethrin 5% cream twice application Receives: Drug: Permethrin Cream, 5% |
| Group C | Experimental | Group C will be given Tab Ivermectin Receives: Drug: Ivermectin 200 µg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure of scabies.
Cure will be labeled if greater han 50% reduction in no of lesions and pruritis observed after 4 weeks of treatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2025
- Study start1 May 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScabiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children Hospital and Institute of Child Health, Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sadaf Wazir, Children Hospital and Institute of Child Health, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06896929
- Sponsor's protocol ID
- 715-24-10-2023ApprovedbyCHUCHS
- Acronym
- not existed
- Status last verified
- Oct 2024
- First submitted
- 20 Mar 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Topical Permethrin 1 Day Verses 2 Day Application Versus Oral Ivermectin for Treatment of Scabies in Children Greater Than 6 Yrs of Age
- ClinicalTrials.gov ID
- NCT06896929
- Acronym / sponsor ID
- not existed / 715-24-10-2023ApprovedbyCHUCHS
- Conditions
- Scabies
- Keywords
- Comparison of permethrin and ivermectin in scabies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Children Hospital and Institute of Child Health, LahoreUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 26 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Scabies is highly contagious,pruritic infestation of skin.Various treatment modalities have been used but search for ideal scabicide is ongoing.we wnt to coduct this study to compare the outcome of permethrin verses ivermectin in children for treatment of scabies .This randomized clinical trial will be done in children hospital lahore for 12 months.Sample size of 90 cases;30 in each group will be included through non probability consecutive sampling.Then patient will be randomly divided into 3 groups.In group A patient will be given 5% permethrin topical application to whole body single application. In Group B ,patients will be given topical permethrin for twice application 24 hrs appart ,In group C patients will be given Tablet Ivermectin single dose 200microgram/kg.Then patients will be examined after 2 weeks and 4 weeks for no of lesions and pruritis and cure will be labeled.All this information will be recorded on performa .Data will be entered and analysed by using SPSS version 26.Three groups will be compared for cure by using chi-square test.P value less than and equal to 0.05 will be considered as significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Permethrin Cream, 5%Group A will be given Permethrin |
| Group B | Experimental | Drug: Permethrin Cream, 5%Group B will be given Permethrin 5% cream twice application |
| Group C | Experimental | Drug: Ivermectin 200 µg/kgGroup C will be given Tab Ivermectin |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age 6-15
- Both genders
- Diagnosed with scabies (as per operational definition)
Key exclusion criteria (4 listed)
- Children with recurrent scabies on medical record
- Known allergy to ivermectin or permethrin.
- Widespread eczema or impetigo.
- Liver dysfunction or renal failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Permethrin Cream, 5%Permethrin 5% cream will be given as a single application | Drug | Group A |
| Permethrin Cream, 5%Permethrin Cream will be given as twice application | Drug | Group B |
| Ivermectin 200 µg/kgGroup C will be given Tab Ivermectin | Drug | Group C |
Primary outcome
Cure of scabies.
Time frame: 12 months
Cure will be labeled if greater han 50% reduction in no of lesions and pruritis observed after 4 weeks of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Permethrin Cream, 5% and Ivermectin 200 µg/kg in people with Scabies, run by Children Hospital and Institute of Child Health, Lahore at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sadaf Wazir, MBBs (97403284231293, sadaffahad302@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure of scabies. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.