Natural History of Urticaria Pigmentosa in Children (UP)

This study has been completed.
Sponsor:
Collaborator:
Society for Pediatric Dermatology
Information provided by:
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00467792
First received: April 30, 2007
Last updated: December 5, 2008
Last verified: December 2008
  Purpose

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.


Condition
Urticaria Pigmentosa

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Natural History of Urticaria Pigmentosa in Children

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Enrollment: 47
Study Start Date: January 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00467792

Locations
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Society for Pediatric Dermatology
Investigators
Principal Investigator: Sheila Galbraith, MD Medical College of Wisconsin
  More Information

No publications provided

Responsible Party: Sheila Galbraith, MD, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT00467792     History of Changes
Other Study ID Numbers: UP
Study First Received: April 30, 2007
Last Updated: December 5, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
urticaria pigmentosa
mastocytosis
mastocytomas

Additional relevant MeSH terms:
Urticaria
Urticaria Pigmentosa
Mastocytosis
Mastocytoma
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Mastocytosis, Cutaneous
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Pigmentation Disorders

ClinicalTrials.gov processed this record on August 21, 2014