Dynamic Epidermal Cooling During Pulsed Dye Laser Treatment of Port Wine Stain Birthmark at High Fluences

NCT00540371 | Completed

• 1 other identifier: 19992154
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to improve the efficacy of pulsed dye laser treatment of port wine stain birthmarks. Involvement in the protocol will involve formal documentation of the level of treatment pain, duration of post-treatment purpura and incidence of side effects. In addition, measurements will be taken of blood substances that promote blood vessel formation/regrowth and non-invasive reflectance measurements and photographs will be taken before and after treatment. The objective of this study is to document the degree of port wine stain lightening, the incidence of side effects and the presence of angiogenic factors induced during treatment with the pulsed dye laser in association with cooling agent. This information ultimately lead to improved treatment.

Conditions

Port Wine Stain

Keywords

Port Wine Stain

Study Arms (1)

Port wine stain Birthmark

Port wine stain Birthmark

Other: Port wine stain Birthmark

Interventions

Port wine stain Birthmark OTHER

Port wine stain Birthmark

Port wine stain Birthmark

Eligibility Criteria

• Age: 1 Month - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

primary care clinic

You may qualify if:

• Diagnosis of PWS birthmark or age and sex matched control of a subject with a PWS birthmark
• Apparent good health as documented by medical history and physical examination
• Ability to understand and carry out subject instructions

You may not qualify if:

• Pregnancy
• History of cutaneous photosensitivity
• History of photodermatoses, skin cancer or other cancer
• Any therapy to the proposed treatment sites within the previous two months
• Current participation in any other investigational drug evaluation
• Concurrent use of known photosensitizing drugs
• Inability to understand and carry out subject instructions

Sponsors & Collaborators

• University of California, Irvine: lead
• Beckman Laser Institute University of California Irvine: collaborator

Study Sites (1)

Beckman Lase Institute Medical Clinic Unversity of California Irvine

Irvine, California, 92612, United States

Location

MeSH Terms

Conditions

Port-Wine Stain

Condition Hierarchy (Ancestors)

Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kristen Kelly, M.D

  Beckman Laser Institue University of California Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kristen Kelly, M.D.,Professor Departments of Dermatology and Surgery

Study Record Dates

• First Submitted: October 4, 2007
• First Posted: October 8, 2007
• Study Start: December 1, 1999
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: October 20, 2022

Record last verified: 2022-10

Locations

US (1)