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

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.

Study Overview

• Status: Completed
• Conditions: Pediculosis
• Intervention / Treatment: Drug: Permethrin 5% topical lotion; Drug: Ivermectin

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 1

Contacts and Locations

Study Locations

• Pakistan
  • KPK
    • Abbottabad, KPK, Pakistan, 22020
      • CMH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 36 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Patients prescribed with topical 5% Permethrin lotion two applications seven days apart and applied overnight.	Drug: Permethrin 5% topical lotion; patients in group A prescribed with 5% topical permethrin lotion two overnight applications seven days apart
Active Comparator: group B; Patients weighing greater than 15kgs prescribed with oral ivermectin 200microgram/kg two doses seven days apart	Drug: Ivermectin; patients in group B and weighing more than 15 kgs were given oral ivermectin 200 microgram/kg two doses seven days apart

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	06 months

Collaborators and Investigators

• Sponsor: Combined Military Hospital Abbottabad
• Investigators: Principal Investigator: Bushra Muzaffar, FCPS, CMH Abbottabad

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): August 31, 2022

Study Registration Dates

• First Submitted: November 22, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Estimate): December 9, 2022

Study Record Updates

• Last Update Posted (Estimate): December 9, 2022
• Last Update Submitted That Met QC Criteria: December 1, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: ivermectin; permethrin 5% lotion
• Additional Relevant MeSH Terms: Skin Diseases; Infections; Parasitic Diseases; Ectoparasitic Infestations; Skin Diseases, Parasitic; Skin Diseases, Infectious; Lice Infestations; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antiparasitic Agents; Permethrin; Ivermectin
• Other Study ID Numbers: CMHAtd-ETH-21-Derm-22

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No