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

NCT05643820 | Completed Phase 1

• 1 other identifier: CMHAtd-ETH-21-Derm-22
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediculosis

Keywords

ivermectin; permethrin 5% lotion

Outcome Measures

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

  06 months

Study Arms (2)

Group A

ACTIVE COMPARATOR

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

Drug: Permethrin 5% topical lotion

group B

ACTIVE COMPARATOR

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

Drug: Ivermectin

Interventions

Permethrin 5% topical lotion DRUG

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

Group A

Ivermectin DRUG

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

group B

Eligibility Criteria

• Age: 8 Years - 36 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Combined Military Hospital Abbottabad: lead

Study Sites (1)

CMH

Abbottabad, KPK, 22020, Pakistan

Location

MeSH Terms

Conditions

Lice Infestations

Interventions

Permethrin; Ivermectin

Condition Hierarchy (Ancestors)

Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Phenyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pyrethrins; Cyclopentane Monoterpenes; Monoterpenes; Terpenes; Macrolides; Polyketides; Lactones

Study Officials

• Bushra Muzaffar, FCPS

  Combined Military Hospital Abbottabad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Huma Farid

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 9, 2022
• Study Start: March 1, 2022
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: December 9, 2022

Record last verified: 2022-12

Locations

PA (1)