Comparison Effectiveness of Oral Ivermectin , 1% Permethrin Shampoo and 4% Dimeticone Liquid Gel in the Treatment of Pediculosis Capitis Among School Children in Chachoengsao Province, Thailand

NCT06332872 | Active Not Recruiting Phase 4

• 1 other identifier: M046q/66
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to Comparison effectiveness of Oral ivermectin , 1% Permethrin shampoo and 4% Dimeticone liquid gel in the treatment of Pediculosis capitis, to assess the prevalence of lice and associated risk factors between severity groups by using questionnaire-based surveys and diagnostic tests among school children in Baan Nayao, Chachoengsao Province, Thailand. The main questions it aims to answer are

• What is more effective between Oral ivermectin , 1% Permethrin shampoo and 4%Dimeticone liquid gel in the treatment of Pediculosis capitis in school children in Baan Nayao, Chachoengsao Province, Thailand?
• What is Prevalence and risk factors of being infected with in head lice in school and community?
• What is Side effects of Oral ivermectin , 1% Permethrin shampoo and 4%Dimeticone liquid gel? Participants will receive three different drugs are
• oral ivermectin
• 4% Dimeticone liquid gel
• 1% Permethrin shampoo Participants voluntarily received oral ivermectin as per medical prescription, with treatment outcomes, side effects, and satisfaction levels monitored following two treatment cycles. Those exhibiting persistent lice infestations were subsequently treated with 1% permethrin shampoo, the standard treatment, while alternatives were provided for individuals allergic to permethrin. These findings will contribute to formulating tailored, effective, and safe treatment regimens for future patients.

Conditions

Pediculus Capitis Infestation; Permethrin Adverse Reaction; Dimethicone Adverse Reaction; Permethrin Allergy; Dimethicone Allergy; Ivermectin; School-age Children

Keywords

Pediculosis capitis; head lice; pediculicides; School; Children; Permethrin; Shampoo; Ivermectin; Dimenticone; gel; liquid gel; pediculosis

Outcome Measures

Primary Outcomes (1)

• Comparison effectiveness of Oral ivermectin , 1% Permethrin shampoo and 4% Dimeticone liquid gel in the treatment of Pediculosis capitis

  Treatment of Pediculosis capitis was considered effective by the absence of live lice

  From enrollment to the end of treatment at 28 days

Secondary Outcomes (3)

• Prevalence of head louse infestation among school children in Chachoengsao Province, Thailand

  From enrollment to the end of screening at 28 days

• Side effects of Oral ivermectin , 1% Permethrin shampoo and 4%Dimeticone liquid gel

  From enrollment to the end of treatment at 28 days

• The association factor of head lice infestation among school children in Chachoengsao Province, Thailand

  From the enrollment to the end of treatment at 28 days

Study Arms (3)

Oral ivermectin

EXPERIMENTAL

For the treatment of head lice infestation, participants are receiving two single doses of oral ivermectin on days 0 and 7 of the experiment. (spaced 7 days apart)

Drug: Oral Ivermectin

Dimeticone liquid gel

EXPERIMENTAL

For the treatment of head lice infestation, participants are receiving one application of 4% dimenticone liquid gel on day 0 of the experiment.

Drug: 4% dimenticone liquid gel

Permethrin shampoo

NO INTERVENTION

Participants are receiving two applications of 1% permethrin shampoo, which is the current drug of choice for Pediculosis capitis, on days 0 and 7. This group is defined as a control group.

Interventions

Oral Ivermectin DRUG

Oral formulation (3mg tablet) Dosage: 2 single doses of 200 mcg/kg given 7 days apart

Oral ivermectin

4% dimenticone liquid gel DRUG

topical formulation (liquid gel) only 1 application

Dimeticone liquid gel

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The participants are studying in Na Yao border patrol police school, Ban Na Isan border patrol police school or Phu Ngam wittaya school.
• Approved consent from the participants' caretaker

You may not qualify if:

• History of Allergic sensitization to these substances
• The participants with chronic scalp disorder
• Those who had used a pediculicide within the previous two weeks
• Those who had recently used bleaches, dyes, or permanent wave products
• Anyone taking trimethoprim or cotrimoxazole at evaluation or during the previous four weeks
• Those who had participated in another clinical trial within one month
• Pregnancy
• Body weight \< 20 kg.
• Loss to follow up in a second dose

Sponsors & Collaborators

• Phramongkutklao College of Medicine and Hospital: lead

Study Sites (1)

Phramongkutklao college of medicine

Bangkok, Thailand

Location

MeSH Terms

Conditions

Lice Infestations

Interventions

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)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 27, 2024
• Study Start: December 15, 2023
• Primary Completion: March 18, 2024
• Study Completion: May 1, 2024
• Last Updated: March 27, 2024

Record last verified: 2024-03

Locations

TH (1)