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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04415034
Other study ID # 0920/UN2.F1/ETIK/2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 1, 2018
Est. completion date September 30, 2018

Study information

Verified date May 2020
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Pediculosis capitis is a parasitic infestation that can cause scalp pruritus and quality of life disturbances. There are two objective measurement for pruritus, visual analog scale (VAS) and 5-D itch scale, which can assess the severity of the scalp pruritus and the latter can also asses the quality of life affected by pruritus. Even though VAS can not be used to evaluate the impact of pruritus on quality of life, it is very easy to use while 5-D itch scale is complex and not child-friendly.

The aim of this study is to determine the relationship between two different pruritus scales and to establish validity of pruritus VAS scale in evaluating quality of life in children with pediculosis capitis. We compare two pruritus scale on students with pediculosis of two boarding school in Bogor, West Java, Indonesia.


Description:

This study used cross sectional design study.

Subjects with eligible criteria were included and informed consent from the parents or legal guardian were obtained.

The diagnosis of pediculosis capitis was made based on the findings of eggs, larva, or an adult parasite on the scalp or in the hair of the students. All subjects were asked for both VAS and 5-D itch scale.The VAS is categorized into five groups based on the point, as follows: 0 for no pruritus, <3 for mild pruritus, ≥ 3 - <7 for moderate pruritus, ≥ 7 - <9 for severe pruritus, and ≥ 9 for very severe pruritus. The 5-D itch scale consists of five parameters: duration, degree, direction, disability (sleep, leisure/social activities, housework/errands, work/school), and distribution of the pruritus with points ranging from one to five.

Data were recorded for statistical analysis, a chi-square test was used to determine the relationship between two categorical variables. The correlation coefficient between the VAS and 5-D itch scale was calculated using Spearman's rank correlation


Recruitment information / eligibility

Status Completed
Enrollment 357
Est. completion date September 30, 2018
Est. primary completion date September 30, 2018
Accepts healthy volunteers No
Gender All
Age group 11 Years to 18 Years
Eligibility Inclusion Criteria:

- Students studying in Junior high school at Boarding School in Bogor with medium length hair who were clinically diagnosed with pediculosis capitis

- Willingness to participate as a research subject (to be interviewed and undergo physical examination), and after being explained the details of the study, granted the headmaster permission to sign consent in their name (informed assent)

Exclusion Criteria:

- Chemical treatment of PC within 10 days before the trial

- History of permethrin hypersensitivity

- Unwillingness to participate as a research subject

- Mild-to-severe secondary infection

- Long or short hair

Study Design


Related Conditions & MeSH terms


Intervention

Other:
VAS and 5-D itch pruritus assessment
All subjects were evaluated for presence of pruritus using VAS and 5-D itch scale

Locations

Country Name City State
Indonesia Pesantren Al Hidayah Cibinong Bogor Jawa Barat

Sponsors (1)

Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pruritus severity (1) Pruritus severity evaluated by visual analog scale (VAS) Baseline, during examination
Primary Pruritus severity (2) Pruritus severity evaluated by 5-D itch scale Baseline, during examination
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