NCT06189768

Brief Summary

The descriptive cross-sectional study was undertaken at Kanti Children's Hospital during the period from January 2020 to June 2021. Ethical approval for the study was obtained from the Institutional Review Board of Kanti Children's Hospital (IRB-KCH). The refence number is 59/2020-021. The study focused on children with hyperpigmentation disorders presenting at the Dermatology Outpatient Department of Kanti Children's Hospital.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
299

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
Last Updated

January 8, 2024

Status Verified

January 1, 2024

Enrollment Period

1.4 years

First QC Date

December 13, 2023

Last Update Submit

January 4, 2024

Conditions

HyperpigmentationPediatric Dermatology

Keywords

Hyperpigmentation disordersNepalPediatricObservational study

Outcome Measures

Primary Outcomes (4)

  • Measure the causes of hyperpigmentation in children aged 0 to 15

    Measure the prevalence of different causes of hyperpigmentation due to any cause in children aged 0 to 15 years presenting to the dermatology outpatient department of Kanti Children's Hospital. Outpatient hospital records were used for collecting the study variables.

    1.5 years

  • Measure the age distribution of children with hyperpigmentation disorders

    The age (in years) of all the children with hyperpigmentation disorders presenting to the outpatient department of Kanti Children's Hospital was recorded. Outpatient hospital records were used for collecting the study variable.

    1.5 years

  • Measure the gender distribution of children with hyperpigmentation disorders

    The gender (male or female) of all the children with hyperpigmentation disorders presenting to the outpatient department of Kanti Children's Hospital was recorded. Outpatient hospital records were used for collecting the study variable.

    1.5 years

  • Measure the caste distribution of children with hyperpigmentation disorders

    The caste of all the children with hyperpigmentation disorders presenting to the outpatient department of Kanti Children's Hospital was recorded. Outpatient hospital records were used for collecting the study variable.

    1.5 years

Study Arms (1)

Children with hyperpigmentation disorder

Children aged 0 to 15 with hyperpigmentation due to any cause presenting to Dermatology Outpatient Department of Kanti Children's Hospital

Eligibility Criteria

AgeUp to 15 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsInclusive of children ranging from newborns to 15 years old with hyperpigmentation due to any cause, the study excluded those admitted to wards with alternative diagnoses.
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Inclusive of children ranging from newborns to 15 years old with hyperpigmentation due to any cause, the study excluded those admitted to wards with alternative diagnoses

You may qualify if:

  • children ranging from newborns to 15 years old with hyperpigmentation due to any cause

You may not qualify if:

  • children admitted to wards

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanti Children's Hospital

Kathmandu, Nepal

Location

MeSH Terms

Conditions

Hyperpigmentation

Condition Hierarchy (Ancestors)

Pigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 13, 2023

First Posted

January 5, 2024

Study Start

January 1, 2020

Primary Completion

June 1, 2021

Study Completion

June 1, 2021

Last Updated

January 8, 2024

Record last verified: 2024-01

Locations

NE(1)