Clinical trial NCT05643820: Comparison of Oral Ivermectin and Permethrin 5% Lotion in Treatment of Pediculosis Capitis
Official title: Comparison of Oral Ivermectin and Permethrin 5% Lotion in Treatment of Pediculosis Capitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pediculosis
Keywords: ivermectin
permethrin 5% lotion
Lead sponsor: Combined Military Hospital Abbottabad
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 36
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 06 months
Secondary outcomes:
Other outcomes:
Locations:
city: Abbottabad
country: Pakistan
facility: CMH
state: KPK
Study officials:
affiliation: Combined Military Hospital Abbottabad
name: Bushra Muzaffar, FCPS
role: PRINCIPAL_INVESTIGATOR
References: