Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06332872 |
| Other study ID # |
M046q/66 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
December 15, 2023 |
| Est. completion date |
May 2024 |
Study information
| Verified date |
March 2024 |
| Source |
Phramongkutklao College of Medicine and Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Study design :
The study consists of two study designs: a quantitative study using a cross-sectional study
to investigate the prevalence of head lice infestation and identify risk factors of head lice
infestation among groups of population diagnosed with varying degrees of infestation; heavy,
medium, and light. Additionally, a field trial will be conducted to compare the effectiveness
of oral ivermectin, 1% Permethrin shampoo, and 4% Dimethicone liquid gel for treatment of
Pediculosis capitis on days 0, 7, 14, and 28.
Study population :
The study population consists of students aged between 6 and 13 years old attending three
schools located in Tha Kradan Subdistrict, Sanam Chai Khet District, Chachoengsao Province.
The treatment allocation for head lice infestation is as follows: students at Na Yao border
patrol police school will receive oral ivermectin, students at Ban Na Isan border patrol
police school will receive 4% Dimethicone liquid gel, and students at Phu Ngam Wittaya School
will receive 1% Permethrin shampoo. All volunteer groups must obtain consent by signing a
parental consent form before participating in the project.
Sample size calculation :
Based on the previous study, Permethrin has an efficacy of 40%, while Ivermectin has an
efficacy of 86.7%. By calculating the sample size using the formula for comparing proportions
in two population groups, we obtain a sample size of 21 per group. To account for potential
loss to follow-up or inability to contact participants, a 20% loss to follow-up rate is
added, resulting in a final sample size of 26 individuals per group. Therefore, 78
individuals will be included in the data collection process.
Data collection :
Data collection was based on two questionnaires and data on head lice infection. The first
questionnaire was a pre-treatment questionnaire asking for informed consent and a
questionnaire regarding basic information. Factors that may be related to lice infection were
the parents of the subjects who completed the questionnaire because the subjects were under
14 years of age. The second post-treatment questionnaire recorded information about allergic
reactions. Potential adverse side effects of using the three groups of drugs and the number
of lice from the second combing.
Data collection on lice infection in this study was based on methods from previous studies.
Where lice infestation is defined as the presence of live lice. This is checked using a nit
comb to check for live lice in the sunlight. Detection of nits with the ability to survive
will also be considered positive. In this research Live lice can be checked by using a nit
comb. The level of lice infection is divided into high levels. medium and little High levels
of lice infestation means finding more than one lice after combing 1 time. Moderate lice
infestation means finding lice after combing 1 time, an amount equal to 1 lice, and low level
lice infestation means not found lice on the first attempt, but live lice or eggs were found
after 20 rounds of combing and inspecting the area above the ears and below the neck. A nit
comb was given to each participant to prevent lice from being infected through the head.
Protocol :
The data collection process began with the give a letter explaining information about the
research and a request for informed consent document to participants. Those interested in
participating in the research will go through a screening process for lice infection by the
research team. The volunteer's identity was verified to match the code set by the researcher.
Screening for history of drug allergies that volunteers in each group will receive. Along
with informing volunteers and parents of how to give the medicine, including possible side
effects and how to behave. In the first lice test, those diagnosed with lice were asked to
complete a questionnaire about factors associated with lice infecting subjects with different
levels of lice. Next, take oral ivermectin, wash your hair with 1% Permethrin shampoo and
leave it for 10 minutes, or marinate your hair with 4% Dimeticone liquid gel and leave it for
15 minutes according to the school group that is divided. Then rinse off with clean water.
Subsequently, follow-up was performed by screening for lice infection after drug use on days
0, 7, 14 and 28 of all samples. On day 7, results for all 3 groups were followed up and a
second treatment was given in the Oral group. Ivermectin and 1% Permethrin shampoo are
administered as the first dose. and follow up on the results of the treatment of lice in all
3 groups on the 14th and 28th day after receiving the first dose. The researcher will fill
out a second questionnaire asking for information about allergies and side effects. Then the
lice are scraped and a sample is collected and counted. Live lice, dead lice, and larval eggs
Then the researcher will record all the numbers and information in the questionnaire.
