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Trial record 42 of 201 for:    hemangioma

Comparison of Electrodessication, Potassium Titanyl Phosphate (KTP) Laser and Pulsed Dye Laser for Treatment of Cherry Angiomata

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ClinicalTrials.gov Identifier: NCT00791908
Recruitment Status : Completed
First Posted : November 17, 2008
Results First Posted : December 21, 2010
Last Update Posted : March 6, 2015
Sponsor:
Information provided by:
Northwestern University

Brief Summary:

The primary objective of this study is to determine whether laser treatments over 6 weeks using the pulsed dye laser system or the potassium titanyl phosphate (KTP) laser are effective in patients with cherry angiomas as observed by a physician provider and the subject.

The investigators hypothesize that the two laser treatments will be an effective tool for treating cherry angiomas. The investigators aim to compare these modalities to electrodessication, as all three modalities are considered the current standard of care. Electrodessication can result in atrophic lesions at the site of the treated cherry angiomas.

In summary, the goal of this project is to compare the non-ablative pulsed dye laser and the AuraTM potassium titanyl phosphate (KTP) laser to each other and to the current standard of care, electrodessication.


Condition or disease Intervention/treatment Phase
Cherry Angioma Procedure: Electrodessication Procedure: Pulsed dye laser (PDL) Procedure: potassium titanyl phosphate (KTP) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Electrodessication, Potassium Titanyl Phosphate (KTP) Laser and Pulsed Dye Laser for Treatment of Cherry Angiomata
Study Start Date : September 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birthmarks Potassium
U.S. FDA Resources

Arm Intervention/treatment
Experimental: electrodessication (ED)
Treatment over 6 weeks using electrodessication (ED) to remove cherry angiomas. Each participant received treatment with PDL, KTP laser, and electrodesiccation to separate randomly selected areas on the torso, with each area bearing 4 cherry angiomata.
Procedure: Electrodessication
Treatment applied to a third of the torso at each study visit.
Experimental: pulsed dye laser (PDL)
Treatment over 6 weeks using pulsed dye laser (PDL) to remove cherry angiomas. Each participant received treatment with PDL, KTP laser, and electrodesiccation to separate randomly selected areas on the torso, with each area bearing 4 cherry angiomata.
Procedure: Pulsed dye laser (PDL)
Laser treatment applied to a third of the torso at each study visit.
Experimental: potassium titanyl phosphate (KTP) laser
Treatment over 6 weeks using potassium titanyl phosphate (KTP) laser to remove cherry angiomas. Each participant received treatment with PDL, KTP laser, and electrodesiccation to separate randomly selected areas on the torso, with each area bearing 4 cherry angiomata.
Procedure: potassium titanyl phosphate (KTP)
Laser treatment applied to a third of the torso at each study visit.



Primary Outcome Measures :
  1. Mean Changes in Color, Texture, and Size of Cherry Angiomata From Baseline to 3 Months After the Second Treatment by Treatment Type as Assessed by Blinded Raters [ Time Frame: Baseline and 3 months ]
    Each subject received all 3 treatments. Serial standardized photographs evaluated for color,texture and size by 2 blinded dermatologists using ordinal visual analog scales from 0 to 10(color: 0=skin colored, 5=red, 10=purple; texture: 0=flat, 5=mildly elevated, 10=elevated; size: 0=0mm, 10=10 mm).



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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 to 95 years.
  • Have at least 12 cherry angiomas (4 per each third of the torso) that have been documented.
  • The subjects are in medically stable condition.
  • The subject has willingness and the ability to understand and provide informed consent for the procedure and is able to communicate with the investigator.
  • Must be willing not to employ other treatment options for cherry angiomas during the course of this study.

Exclusion Criteria:

  • Under 18 years of age and over 95 years of age
  • Pregnancy or lactation.
  • Subjects who are unable to understand the protocol or to give informed consent.
  • Subjects cannot have had previous laser treatment in the last 6 months before enrollment.
  • Subjects have a cardiac defibrillator or pacemakers that may interact with the electrodesiccation technique.
  • Subjects have no serious medical conditions that would contradict participation in the research.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00791908


Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Murad Alam, MD Northwestern University

Publications of Results:
Responsible Party: Murad Alam, Northwestern University
ClinicalTrials.gov Identifier: NCT00791908     History of Changes
Other Study ID Numbers: MA-STU81
First Posted: November 17, 2008    Key Record Dates
Results First Posted: December 21, 2010
Last Update Posted: March 6, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms