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
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