Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Role of Angiogenesis in Dermatologic Diseases: A Potential Therapeutic Target

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Beckman Laser Institute University of California Irvine
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00842283
First received: February 11, 2009
Last updated: November 18, 2014
Last verified: November 2014
  Purpose

The researcher believe that pro-angiogenic factors are upregulated in a wide range of dermatologic diseases including port wine stains, hemangiomas, angiofibromas, Kaposi's sarcoma, angiosarcoma, scars, rosacea and psoriasis.

The researcher can perform immunohistochemistry and/or microarray analysis and/or quantitative polymerase chain reaction on previously biopsied skin specimens and newly biopsied skin specimens to evaluate the expression of various angiogenic factors in these dermatologic diseases.

In addition, some of the skin specimens may be utilized to make cell cultures to study expression of angiogenic factors and interactions of cells in dermatologic disease.


Condition Intervention Phase
Dermatologic Diseases
Other: skin tissue sample
Phase 1

Study Type: Observational
Official Title: Role of Angiogenesis in Dermatologic Diseases: A Potential Therapeutic Target

Resource links provided by NLM:


Further study details as provided by University of California, Irvine:

Primary Outcome Measures:
  • Factors in dermatologic diseases. [ Time Frame: up to 4 weeks ] [ Designated as safety issue: No ]
    Evaluate the role of angiogenesis in cutaneous disease and ultimately, facilitate implementation of anti-angiogenic therapy in a wide range of dermatologic diseases including port wine stains, hemangiomas, angiofibromas, Kaposi's sarcoma, angiosarcoma, scars, rosacea and psoriasis.


Estimated Enrollment: 100
Study Start Date: November 2008
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
dermatologic diseases
skin tissue sample
Other: skin tissue sample
skin tissue sample
Other Name: skin tissue sample

Detailed Description:

Previously collected biospecimens from various dermatologic diseases including port wine stains, hemangiomas, angiofibromas, Kaposi's sarcoma, angiosarcoma, scars, rosacea and psoriasis will be evaluated for markers of angiogenesis. Additionally, researcher can use discarded human skin tissue samples from skin closed to biopsy/surgery sites which are removed for closure but are not submitted for histopathologic analysis.

Specimens collected will be processed and microarray analysis, qPCR and/or immunohistochemistry performed to evaluate expression of various angiogenic factors and their receptors including: vascular endothelial growth factor, basic fibroblast growth factor, angiopoietin 1, angiopoietin 2, matrix metalloproteinase, tissue inhibitor metalloproteinase I and thrombospondin-1, Angiotensin 2 receptor.

Tissue samples will be isolated and cultured of the three cell types, endothelial cells, keratinocytes, and fibroblasts. Tissue samples will be digested to isolate the cells which will be cultured separately and then incorporated into an in-vitro model to observe how blood vessels form in skin affected by port wine stains as compared to vessel growth in unaffected skin.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Tissue sample will be collected from Dermatopathology Lab, Pathology lab, Discard tissue from dermatologic surgery at University of California Irvine.

Criteria

Inclusion Criteria:

  • 18 years of age or older.
  • willing to have a skin biopsy

Exclusion Criteria:

  • under 18 years of age
  • unable to carry out instructions
  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: NCT00842283

Locations
United States, California
Beckman Laser Institute Medical clinic
Irvine, California, United States, 92612
Gottschalk Medical Plaza
Irvine, California, United States, 92612
Sponsors and Collaborators
Montana Compton
Beckman Laser Institute University of California Irvine
Investigators
Principal Investigator: Kristen Kelly, MD Beckman Laser Institute University of California Irvine
  More Information

No publications provided

Responsible Party: Montana Compton, Administrative Nurse Research Coordinator Beckman Laser Institute, University of California, Irvine
ClinicalTrials.gov Identifier: NCT00842283     History of Changes
Other Study ID Numbers: NIH/LAMMP-2007-6094
Study First Received: February 11, 2009
Last Updated: November 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
dermatologic diseases

Additional relevant MeSH terms:
Skin Diseases

ClinicalTrials.gov processed this record on November 20, 2014