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CompletedNCT05643820Updated Dec 9, 2022

Comparison of Oral Ivermectin and Permethrin 5% Lotion in Treatment of Pediculosis Capitis

A Phase 1 interventional study of Permethrin 5% topical lotion and Ivermectin in Pediculosis, sponsored by Combined Military Hospital Abbottabad. Completed at 1 site in Pakistan. Open to participants aged 8 Years to 36 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-09.

Sponsored by Combined Military Hospital Abbottabad · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Mar 2022, registered Nov 2022).
Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
8 Years to 36 Years
Sex
All
01

Study summary

In children, pediculosis is a common ectoparasitic infestation. Infestation of head lice (Pediculus humanus capitis) causes a variety of physical symptoms, including pruritus, excoriation, cervical lymphadenopathy, and conjunctivitis1. It also has a number of negative social consequences, including parental anxiety and stigmatization of infested children2.

It is a significant public health issue that primarily affects school-aged children aged 8 to 113. In developing nations, prevalence rates of up to 40% have been reported4. The four urban areas of KPK (NWFP) reported prevalence of 36.7%5. People with a low socioeconomic background and poor hygiene are more likely to be affected6.

Pediculosis capitis has been treated using a variety of treatment modalities. They include both physician prescription and over-the-counter medications. Permethrin or ivermectin had been used topically or orally. Permethrin is a neurotoxin that is synthesized. It is a pyrethroid neurotoxic that targets voltage-sensitive Sodium ion receptors in the neurological system of the insect, triggering nerve depolarization, hyperexcitation, muscular paralysis, and, eventually, parasite death7. Ivermectin is antiparasitic medication, it is possible to treat diseases like lymphatic filariasis, and ectoparasite infestations, primarily scabies, with ivermectin because it binds to glutamate gated chloride ion receptors of invertebrates and disrupts neurotransmission8.

The rationale of this study is to study while comparing effectiveness of oral ivermectin and topical permethrin in management of pediculosis. The topical medication usage is problematic and had reported drug resistance9. There has been less regional or national research on the effectiveness of oral Ivermectin, so doctors less frequently use it in our department. Instead, the patients are treated for pediculosis capitis with topical Permethrin.

02

Conditions studied

  • Pediculosis

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Keywords

  • ivermectin
  • permethrin 5% lotion
03

In context

Lice Infestations

58 studies on the registry are indexed under Lice Infestations; 4 are open to participants now.

This study's enrollment of 60 is below the median of 118 across 56 interventional studies indexed under Lice Infestations.

Browse Lice Infestations studies →

Lead sponsor

Combined Military Hospital Abbottabad is the lead sponsor of 24 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
8 Years to 36 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

both genders with live detected on clinical examination and by combing wet hair with a fine toothed lice detection comb ages 8-36 years weight >15 kgs

Exclusion criteria

Exclusion Criteria:

pregnancy breast feeding using any pediculicidal medication within the preceding two weeks of treatment hairstyle that may be difficult to comb

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Group A

    Patients prescribed with topical 5% Permethrin lotion two applications seven days apart and applied overnight.

    Drug: Permethrin 5% topical lotion

  • Active comparator
    group B

    Patients weighing greater than 15kgs prescribed with oral ivermectin 200microgram/kg two doses seven days apart

    Drug: Ivermectin

Interventions

  • DrugPermethrin 5% topical lotion

    patients in group A prescribed with 5% topical permethrin lotion two overnight applications seven days apart

  • DrugIvermectin

    patients in group B and weighing more than 15 kgs were given oral ivermectin 200 microgram/kg two doses seven days apart

06

What researchers measure

Primary outcomes

  1. comparison of oral ivermectin and 5%permethrin lotion the treatment of pediculosis capitis assessed after two applications seven days apart and reassessed at 14 days

    treatment was considered to be effective with complete absence of symptoms i.e pruritus and the absence of live lice after combing wet hair with a fine toothed detection comb

    Time frame: 06 months

07

Study locations

1 site
  • CMH
    Abbottabad, KPK 22020, Pakistan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05643820
Lead sponsor
Combined Military Hospital Abbottabad
Responsible party
Huma Farid (Dr. Huma Farid, Combined Military Hospital Abbottabad) — Principal investigator
First posted
Dec 9, 2022
Start date
Mar 1, 2022
Primary completion
Aug 31, 2022
Completion
Aug 31, 2022
Last update
Dec 9, 2022

Study contacts

Bushra Muzaffar, FCPS
principal investigator · Combined Military Hospital Abbottabad

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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