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

M046q/66

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.

2023-12-15

2024-03-18

2024-05-01

Active (not recruiting)

Early phase I

117

Inclusion Criteria: 1. The participants are studying in Na Yao border patrol police school, Ban Na Isan border patrol police school or Phu Ngam wittaya school. 2. Approved consent from the participants' caretaker Exclusion Criteria: 1. History of Allergic sensitization to these substances 2. The participants with chronic scalp disorder 3. Those who had used a pediculicide within the previous two weeks 4. Those who had recently used bleaches, dyes, or permanent wave products 5. Anyone taking trimethoprim or cotrimoxazole at evaluation or during the previous four weeks 6. Those who had participated in another clinical trial within one month Additional exclusion criteria for ivermectin 1. Pregnancy 2. Body weight \< 20 kg. 3. Loss to follow up in a second dose

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 117, 'type': 'ESTIMATED'}}

2024-03-27