Comparison of Oral Ivermectin and Permethrin 5% Lotion in Treatment of Pediculosis Capitis
Primary Purpose
Pediculosis
Status
Completed
Phase
Phase 1
Locations
Pakistan
Study Type
Interventional
Intervention
Permethrin 5% topical lotion
Ivermectin
Sponsored by
About this trial
This is an interventional treatment trial for Pediculosis focused on measuring ivermectin, permethrin 5% lotion
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
Sites / Locations
- CMH
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group A
group B
Arm Description
Patients prescribed with topical 5% Permethrin lotion two applications seven days apart and applied overnight.
Patients weighing greater than 15kgs prescribed with oral ivermectin 200microgram/kg two doses seven days apart
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05643820
First Posted
November 22, 2022
Last Updated
December 1, 2022
Sponsor
Combined Military Hospital Abbottabad
1. Study Identification
Unique Protocol Identification Number
NCT05643820
Brief Title
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
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Combined Military Hospital Abbottabad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediculosis
Keywords
ivermectin, permethrin 5% lotion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Patients prescribed with topical 5% Permethrin lotion two applications seven days apart and applied overnight.
Arm Title
group B
Arm Type
Active Comparator
Arm Description
Patients weighing greater than 15kgs prescribed with oral ivermectin 200microgram/kg two doses seven days apart
Intervention Type
Drug
Intervention Name(s)
Permethrin 5% topical lotion
Intervention Description
patients in group A prescribed with 5% topical permethrin lotion two overnight applications seven days apart
Intervention Type
Drug
Intervention Name(s)
Ivermectin
Intervention Description
patients in group B and weighing more than 15 kgs were given oral ivermectin 200 microgram/kg two doses seven days apart
Primary Outcome Measure Information:
Title
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
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bushra Muzaffar, FCPS
Organizational Affiliation
Combined Military Hospital Abbottabad
Official's Role
Principal Investigator
Facility Information:
Facility Name
CMH
City
Abbottabad
State/Province
KPK
ZIP/Postal Code
22020
Country
Pakistan
12. IPD Sharing Statement
Learn more about this trial
Comparison of Oral Ivermectin and Permethrin 5% Lotion in Treatment of Pediculosis Capitis
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