Natural History of Urticaria Pigmentosa in Children

Urticaria Pigmentosa Clinical Trial

— UP  

Official title:

Natural History of Urticaria Pigmentosa in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00467792
• Other study ID #: UP
• Status: Completed
• Phase: N/A
• First received: April 30, 2007
• Last updated: December 5, 2008
• Start date: January 2006
• Est. completion date: June 2008

Study information

• Verified date: December 2008
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Less than 3 mastocytomas

• Diffuse mastocytosis

• TMEP

• residence is out of Wisconsin/Illinois area or the United States

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Urticaria
• Urticaria Pigmentosa

Locations

Country	Name	City	State
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Society for Pediatric Dermatology

Country where clinical trial is conducted

United States,