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Combined Use of Pulsed Dye Laser and Topical Antiangiogenic Agents for Treatment of Port Wine Stain Birthmarks

This study has been terminated.
(We have decided not to pursue the study)
Sponsor:
Information provided by (Responsible Party):
Montana Compton, University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00969397
First received: August 31, 2009
Last updated: October 28, 2011
Last verified: October 2011

August 31, 2009
October 28, 2011
November 2009
September 2011   (final data collection date for primary outcome measure)
Improve PWS lesion blanching. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00969397 on ClinicalTrials.gov Archive Site
To determine whether the combined use of pulsed dye laser (PDL) therapy and topical agent will improve PWS outcome. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Combined Use of Pulsed Dye Laser and Topical Antiangiogenic Agents for Treatment of Port Wine Stain Birthmarks
phase1/2 Combine PDL/Topical Agent for Treatment of PWS

The researcher want to improve port wine stain (PWS) therapeutic outcome in response to laser therapy. The researcher want to determine whether the combined use of pulsed dye laser (PDL) therapy and topical tacrolimus or pimecrolimus will improve PWS therapeutic outcome.

Both topical agents inhibit nuclear factor of activated T-cells (NFAT) which blocks the calcineurin/NFAT pathway inhibiting endothelial cell proliferation and angiogenesis, which could be very useful in preventing PWS recanalization.

The combined use of PDL to induce PWS blood vessel injury, and topical antiangiogenic agents to prevent PWS blood vessel angiogenesis and recanalization after laser therapy, will improve PWS lesion blanching.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Port Wine Stain
Other: combined PDL nad Topical Agent
tacrolimuS/pimecrolimus
Other Name: Protopic/Elidel
Experimental: combined PDL and topical agent
PWS
Intervention: Other: combined PDL nad Topical Agent
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
September 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 16 years of age and older
  • Have PWS suitable for comparison testing as determined by the study doctor

Exclusion Criteria:

  • Less than 16 years old
  • Are pregnant
  • Have skin cancer
  • Currently taking immunosuppressive or steroids or photosensitizing drugs
  • Current participation in any other investigational drug evaluation
  • Concurrent use of known photosensitizing drugs
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00969397
NIH K-24, LAMMP
Yes
Montana Compton, University of California, Irvine
Montana Compton
Not Provided
Principal Investigator: John S Nelson, M.D,PhD Beckman Laser Institute University of California Irvine
University of California, Irvine
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP