Tinea CapitisNCT00224926
The Natural Course of Trichophyton Tonsurans Carriage and Infection: A Molecular and Biochemical Evaluation
An observational study of Tinea Capitis, run by Children's Mercy Hospital Kansas City at 1 site in United States.
Trial summary
To explore carrier and infection status of T.tonsurans tinea capitis and characterize the host-pathogen interaction as it relates to the disease presentation. The general hypothesis for this study is as follows: the type of genotypic and phenotypic variant to which a child is exposed accounts for the presentation… Read more about this study
- Who is it for?
- Ages 2 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Tinea Capitis
- What is being tested?
- Scalp Brushing
- Type of treatment
- Surgery or procedure
- How many people
- 446 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Sep 2005
- 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 2 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: preschool aged children
Who may be able to join
- Preschool aged children will be eligible.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Mercy Hospital
Kansas City, Missouri, 64108
About this study
To explore carrier and infection status of T.tonsurans tinea capitis and characterize the host-pathogen interaction as it relates to the disease presentation. The general hypothesis for this study is as follows: the type of genotypic and phenotypic variant to which a child is exposed accounts for the presentation status observed in Trichophyton tonsurans infection.The global outcome of this investigation is to reveal potential new drug targets designed to improve treatment outcomes in these children.
Read the detailed description
Tinea capitis is an overwhelmingly prevalent disease of childhood estimated to be present in approximately 1 in 20 children at any point in time with an equal number of children serving as carriers of the fungal pathogen. Despite the widespread nature of the disease, the natural course of the infection remains incompletely described. The study will be driven by the following hypothesis: the type of genotypic and phenotypic variant to which a child is exposed accounts for the presentation status observed in Trichophyton tonsurans infection.
A fungal scalp culture will be acquired from all participants using a brush culture technique. Samples will be collected once a month over a two year time period.
- Conditions
- Tinea Capitis
- Being tested
- Scalp Brushing
- Keywords
- Tinea Capitis
- Medical subject headings
- Tinea Capitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scalp BrushingProcedure or surgery
sterile, soft-head toothbrush massaged on scalp
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startSep 2003
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tinea CapitisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Sponsor
- Investigators
- Susan Rahman, PharmD, Principal investigator, Children's Mercy Hosptials and Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00224926
- Sponsor's protocol ID
- PPRU 10704
- Status last verified
- Sep 2011
- First submitted
- 21 Sep 2005
- Last updated
- 19 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Natural Course of Trichophyton Tonsurans Carriage and Infection: A Molecular and Biochemical Evaluation
- ClinicalTrials.gov ID
- NCT00224926
- Acronym / sponsor ID
- PPRU 10704
- Conditions
- Tinea Capitis
- Keywords
- Tinea Capitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 446 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Sep 2003
- Study completion
- Sep 2005 (actual)
- First posted
- 23 Sep 2005 (estimated)
- 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.
To explore carrier and infection status of T.tonsurans tinea capitis and characterize the host-pathogen interaction as it relates to the disease presentation. The general hypothesis for this study is as follows: the type of genotypic and phenotypic variant to which a child is exposed accounts for the presentation status observed in Trichophyton tonsurans infection.The global outcome of this investigation is to reveal potential new drug targets designed to improve treatment outcomes in these children.
Detailed description
Tinea capitis is an overwhelmingly prevalent disease of childhood estimated to be present in approximately 1 in 20 children at any point in time with an equal number of children serving as carriers of the fungal pathogen. Despite the widespread nature of the disease, the natural course of the infection remains incompletely described. The study will be driven by the following hypothesis: the type of genotypic and phenotypic variant to which a child is exposed accounts for the presentation status observed in Trichophyton tonsurans infection.
A fungal scalp culture will be acquired from all participants using a brush culture technique. Samples will be collected once a month over a two year time period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- preschool aged children
Key inclusion criteria (1 listed)
- Preschool aged children will be eligible.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scalp Brushingsterile, soft-head toothbrush massaged on scalp | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 19 Sep 2011.
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Tinea Capitis
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.
Susan Rahman, PharmD principal investigator
Children's Mercy Hosptials and Clinics
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 Tinea Capitis, run by Children's Mercy Hospital Kansas City at 1 site in United States.
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 19 Sep 2011. 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 United States. 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.
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 19 Sep 2011.