Urticaria PigmentosaUPNCT00467792
Natural History of Urticaria Pigmentosa in Children
An observational study of Urticaria Pigmentosa, run by Medical College of Wisconsin at 1 site in United States.
Trial summary
The purpose of this study is to determine how long the skin lesions usually last and what kind of symptoms and signs children with urticaria pigmentosa may develop over the years. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Urticaria Pigmentosa
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Jun 2008
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This study involves children, of age 0-18 years old who are diagnosed with urticaria pigmentosa during their visit at the Pediatric Dermatology Clinic.
Who may be able to join
- Age 0-18 years old at diagnosis of UP
- 3 or more mastocytomas (diagnosis can be based on clinical exam; biopsy only necessary if diagnosis is in question)
- patients recruited from Children's Hospital of Wisconsin Dermatology Clinic
Who cannot join
- Less than 3 mastocytomas
- Diffuse mastocytosis
- TMEP
- residence is out of Wisconsin/Illinois area or the United States
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
The purpose of this study is to determine how long the skin lesions usually last and what kind of symptoms and signs children with urticaria pigmentosa may develop over the years. This information will allow physicians to better care for patients who have been diagnosed with this disease and to provide their parents with more complete information regarding what to expect for the future of their child. This research is being done because many unanswered questions remain regarding children with urticaria pigmentosa and its course.
Read the detailed description
This study involves children, of age 0-18 years old who are diagnosed with urticaria pigmentosa during their visit at the Pediatric Dermatology Clinic. Parents and child will be interviewed to gain medical and family history, in addition, the doctor will perform a physical exam and take a photograph. Children older than 4 years of age will complete the "Children Dermatology Life Quality Index." Children less than 4 years of age with an active disease will have laboratory tests requiring a sample of blood (1 teaspoon).
Patients will receive $50 for their first office visit as financial reimbursement for participating in the study.
- Conditions
- Urticaria Pigmentosa
- Keywords
- urticaria pigmentosa, mastocytosis, mastocytomas
- Medical subject headings
- Urticaria Pigmentosa, Mastocytosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2007 (estimated)
- Study startJan 2006
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urticaria PigmentosaStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- 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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Society for Pediatric Dermatology
- Investigators
- Sheila Galbraith, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00467792
- Sponsor's protocol ID
- UP
- Acronym
- UP
- Status last verified
- Dec 2008
- First submitted
- 30 Apr 2007
- Last updated
- 8 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History of Urticaria Pigmentosa in Children
- ClinicalTrials.gov ID
- NCT00467792
- Acronym / sponsor ID
- UP / UP
- Conditions
- Urticaria Pigmentosa
- Keywords
- urticaria pigmentosa, mastocytosis, mastocytomas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Society for Pediatric Dermatology
- Study start
- Jan 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 1 May 2007 (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.
The purpose of this study is to determine how long the skin lesions usually last and what kind of symptoms and signs children with urticaria pigmentosa may develop over the years. This information will allow physicians to better care for patients who have been diagnosed with this disease and to provide their parents with more complete information regarding what to expect for the future of their child. This research is being done because many unanswered questions remain regarding children with urticaria pigmentosa and its course.
Detailed description
This study involves children, of age 0-18 years old who are diagnosed with urticaria pigmentosa during their visit at the Pediatric Dermatology Clinic. Parents and child will be interviewed to gain medical and family history, in addition, the doctor will perform a physical exam and take a photograph. Children older than 4 years of age will complete the "Children Dermatology Life Quality Index." Children less than 4 years of age with an active disease will have laboratory tests requiring a sample of blood (1 teaspoon).
Patients will receive $50 for their first office visit as financial reimbursement for participating in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This study involves children, of age 0-18 years old who are diagnosed with urticaria pigmentosa during their visit at the Pediatric Dermatology Clinic.
Key inclusion criteria (3 listed)
- Age 0-18 years old at diagnosis of UP
- 3 or more mastocytomas (diagnosis can be based on clinical exam; biopsy only necessary if diagnosis is in question)
- patients recruited from Children's Hospital of Wisconsin Dermatology Clinic
Key exclusion criteria (4 listed)
- Less than 3 mastocytomas
- Diffuse mastocytosis
- TMEP
- residence is out of Wisconsin/Illinois area or the United States
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
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 8 Dec 2008.
Related trials for Urticaria Pigmentosa
RecruitingPhase 2
(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis
Advanced Systemic Mastocytosis (AdvSM), SM With an Associated Hematologic Neoplasm (SM-AHN)
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.
Sheila Galbraith, MD principal investigator
Medical College of Wisconsin
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 Urticaria Pigmentosa, run by Medical College of Wisconsin 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 3 inclusion and 4 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 Dec 2008. 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 8 Dec 2008.