ScabiesEarly Phase 1NCT07247630
Comparison of Permethrin-Based Treatment Strategies Against Scabies in Infants and Young Children
A Early Phase 1 study testing Permethrin 5% in people with Scabies, run by College of Physicians and Surgeons Pakistan at 1 site in Pakistan.
Trial summary
To compare the efficacy of different permethrin-based therapies for scabies infestations in infants and young children. Read more about this study
- Who is it for?
- Ages 1 month to 4 years
- Conditions the study is for
- Scabies
- What is being tested?
- Permethrin 5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jan 2026to 15 Jun 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 1 month to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1 month to 4 years age.
- Both gender
- Scabies as defined in operational definition
Who cannot join
- • Drug sensitivity test results for hypersensitivity to permethrin
- Having renal or hepatic impairment.
- Individuals with additional long-term skin and systemic disorders (such as diabetes, hypertension, asthma, epilepsy, acne, psoriasis)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Pak emirates military hospital,Rawalpindi
Rawalpindi, Punjab Province, 00666
About this study
To compare the efficacy of different permethrin-based therapies for scabies infestations in infants and young children.
Read the detailed description
Globally, Scabies infects 300 million people each year and among children of developing countries, its prevalence is estimated to be about 5-10%.In Pakistan, Scabies accounts for 38% of dermatological diseases. Males are more prone to infestation than females, and early school- aged children are the most vulnerable as it is usually transmitted by prolonged skin-skin contact.
It was more widespread in urban than in rural areas with a distinct seasonal pattern, with the biggest infestation occurring in the winter and the lowest in the summer with all risk factors accounting for 89% of the variation in its prevalence.The classic scabies symptoms include an erythematous papular eruption, burrows, and intense itching with a predilection for fingers, axilla, elbows, waist, belly, groin, genital area, etc. Several antiscabietic treatment options exist, including topically applied permethrin, benzyl benzoate (BB) and crotamiton, and oral ivermectin.5 Repeated administration of topical permethrin 5%, topical BB 10-25% or systemic ivermectin dosed at 200 μg/kg body weight is currently recommended as first-line treatment by the 2017 European guidelines for the management of scabies.Permethrin, a synthetic pyrethroid with scabicidal and ovicidal activity, disrupts the function of the voltage-gated sodium channels in the neuronal membrane of the mites, resulting in paralysis and death. Permethrin is highly effective against scabies and well- tolerated without major side-effects, as it is minimally absorbed through the skin and rapidly eliminated, thus exerting minimal systemic presence in humans.Hence, it is recommended as a first-line therapy for adults and children in many countries
- Conditions
- Scabies
- Being tested
- Permethrin 5%
- Keywords
- Permethrin based treatment strategies
- Medical subject headings
- Scabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Permethrin 5%Drug
permethrin application
| Study group | Role | What they receive |
|---|---|---|
| Standard permethrin treatment | Active comparator | Standard permethrin treatment Receives: Drug: Permethrin 5% |
| Intensified permethrin treatment | Active comparator | Intensified permethrin treatment Receives: Drug: Permethrin 5% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment of scabies
For efficacy, we will see microscopy (presence of any one by examine skin scraping under a microscope for mites(eyeless and spherical in shape with eight legs parasite)/eggs (oval shape).The absence of these will be considered significant.
Measured: 15 days
Secondary outcomes (2)
Scabies
Absence of burrows on skin
Measured: 15 days
Scabies
Absence of pruritus
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start15 Jan 2026 (estimated)
- Primary completion15 Mar 2026 (estimated)
- Study completion15 Jun 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- College of Physicians and Surgeons Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shanza zafar, Pak Emirates Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247630
- Sponsor's protocol ID
- A/28/ERC.63.25
- Status last verified
- Feb 2026
- First submitted
- 1 Oct 2025
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Permethrin-Based Treatment Strategies Against Scabies in Infants and Young Children
- ClinicalTrials.gov ID
- NCT07247630
- Acronym / sponsor ID
- A/28/ERC.63.25
- Conditions
- Scabies
- Keywords
- Permethrin based treatment strategies
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- College of Physicians and Surgeons PakistanUniversity, hospital or other
- Study start
- 15 Jan 2026 (estimated)
- Primary completion
- 15 Mar 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 25 Nov 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.
To compare the efficacy of different permethrin-based therapies for scabies infestations in infants and young children.
Detailed description
Globally, Scabies infects 300 million people each year and among children of developing countries, its prevalence is estimated to be about 5-10%.In Pakistan, Scabies accounts for 38% of dermatological diseases. Males are more prone to infestation than females, and early school- aged children are the most vulnerable as it is usually transmitted by prolonged skin-skin contact.
It was more widespread in urban than in rural areas with a distinct seasonal pattern, with the biggest infestation occurring in the winter and the lowest in the summer with all risk factors accounting for 89% of the variation in its prevalence.The classic scabies symptoms include an erythematous papular eruption, burrows, and intense itching with a predilection for fingers, axilla, elbows, waist, belly, groin, genital area, etc. Several antiscabietic treatment options exist, including topically applied permethrin, benzyl benzoate (BB) and crotamiton, and oral ivermectin.5 Repeated administration of topical permethrin 5%, topical BB 10-25% or systemic ivermectin dosed at 200 μg/kg body weight is currently recommended as first-line treatment by the 2017 European guidelines for the management of scabies.Permethrin, a synthetic pyrethroid with scabicidal and ovicidal activity, disrupts the function of the voltage-gated sodium channels in the neuronal membrane of the mites, resulting in paralysis and death. Permethrin is highly effective against scabies and well- tolerated without major side-effects, as it is minimally absorbed through the skin and rapidly eliminated, thus exerting minimal systemic presence in humans.Hence, it is recommended as a first-line therapy for adults and children in many countries
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard permethrin treatment | Active comparator | Drug: Permethrin 5%Standard permethrin treatment |
| Intensified permethrin treatment | Active comparator | Drug: Permethrin 5%Intensified permethrin treatment |
Who may qualify
- Ages
- 1 month to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 1 month to 4 years age.
- Both gender
- Scabies as defined in operational definition
Key exclusion criteria (3 listed)
- • Drug sensitivity test results for hypersensitivity to permethrin
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 5%permethrin application | Drug | Intensified permethrin treatment, Standard permethrin treatment |
Primary outcome
Treatment of scabies
Time frame: 15 days
For efficacy, we will see microscopy (presence of any one by examine skin scraping under a microscope for mites(eyeless and spherical in shape with eight legs parasite)/eggs (oval shape).The absence of these will be considered significant.
2 secondary outcomes
Scabies
Time frame: 15 days
Scabies
Time frame: 15 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Scabies
Not yet recruiting
Assessment of the Prevalence of Rheumatic Heart Disease in School Settings in Mayotte and the Acquisition of Ultrasound Sequences Guided by Artificial Intelligence
Rheumatic Heart Diseases, Scabies
Active, not recruitingPhase 2
Ivermectin Therapy for Scabies Infection in Children Younger Than 5 Years of Age (ITCHY Study)
Scabies; Itch, Scabies
RecruitingPhase 3
Better Options for Lymphatic Filariasis Treatment
Lymphatic Filariasis, Scabies
Not yet recruitingObservational study
Secondary Bacterial Infections and Nasal Colonization in Scabies and Atopic Dermatitis
Atopic Dermatitis (AD), Scabies
Not yet recruiting
Early Detection and AI-Based Management of Skin-Related Neglected Tropical Diseases in Sub-Saharan Africa by Frontline Health Workers
Skin and Connective Tissue Diseases, Neglected Tropical Diseases
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Permethrin 5% in people with Scabies, run by College of Physicians and Surgeons Pakistan 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 3 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: opening soon, as of the sponsor's last update on 3 Feb 2026. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shanza zafar, MBBs (+923425316096, shanza444@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment of scabies (time frame: 15 days). 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 3 Feb 2026.