HyperpigmentationNCT06189768
A Study on Pigmentation Disorders in Children
An observational study of Hyperpigmentation and Pediatric Dermatology, run by Nepal Health Research Council at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperpigmentation, Pediatric Dermatology
- How many people
- 299 participants
- Where
- 1 siteNepal
- Study dates
- 1 Jan 2020to 1 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 15 years
- All sexes
- Healthy volunteers accepted
- Child
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
Who may be able to join
- children ranging from newborns to 15 years old with hyperpigmentation due to any cause
Who cannot join
- children admitted to wards
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Study on Pigmentation Disorders in Children in a Tertiary Care Children's Hospital.
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.
- Conditions
- Hyperpigmentation, Pediatric Dermatology
- Keywords
- Hyperpigmentation disorders, Nepal, Pediatric, Observational study
- Medical subject headings
- Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start1 Jan 2020
- Primary completion1 Jun 2021
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperpigmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nepal Health Research Council
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Abal Baral, Nepal Health Research Council
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06189768
- Sponsor's protocol ID
- 59/2020-021
- Status last verified
- Jan 2024
- First submitted
- 13 Dec 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study on Pigmentation Disorders in Children in a Tertiary Care Children's Hospital.
- ClinicalTrials.gov ID
- NCT06189768
- Acronym / sponsor ID
- 59/2020-021
- Conditions
- Hyperpigmentation, Pediatric Dermatology
- Keywords
- Hyperpigmentation disorders, Nepal, Pediatric, Observational study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Nepal Health Research CouncilOther government
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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
Key inclusion criteria (1 listed)
- children ranging from newborns to 15 years old with hyperpigmentation due to any cause
Key exclusion criteria (1 listed)
- children admitted to wards
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure the causes of hyperpigmentation in children aged 0 to 15
Time frame: 1.5 years
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.
Measure the age distribution of children with hyperpigmentation disorders
Time frame: 1.5 years
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.
Measure the gender distribution of children with hyperpigmentation disorders
Time frame: 1.5 years
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.
Measure the caste distribution of children with hyperpigmentation disorders
Time frame: 1.5 years
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperpigmentation and Pediatric Dermatology, run by Nepal Health Research Council at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the causes of hyperpigmentation in children aged 0 to 15 (time frame: 1.5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2024; AzTrials last refreshed its copy on 31 Oct 2026.