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

Sponsor:	Northwestern University
Information provided by:	Northwestern University
ClinicalTrials.gov Identifier:	NCT00791908

Purpose

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	Intervention
Cherry Angioma	Procedure: Electrodessication Procedure: Pulsed dye laser (PDL) Procedure: potassium titanyl phosphate (KTP)

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Comparison of Electrodessication, Potassium Titanyl Phosphate (KTP) Laser and Pulsed Dye Laser for Treatment of Cherry Angiomata

Resource links provided by NLM:

MedlinePlus related topics: Birthmarks Potassium

Drug Information available for: Potassium chloride

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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).

Enrollment:	15
Study Start Date:	September 2006
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	18 Years to 95 Years
Genders Eligible for Study:	Both
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.

Contacts and Locations

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

More Information

Publications:

Collyer J, Boone SL, White LE, Rademaker A, West DP, Anderson K, Kim NA, Smith S, Yoo S, Alam M. Comparison of treatment of cherry angiomata with pulsed-dye laser, potassium titanyl phosphate laser, and electrodesiccation: a randomized controlled trial. Arch Dermatol. 2010 Jan;146(1):33-7.

Responsible Party:	Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:	NCT00791908 History of Changes
Other Study ID Numbers:	MA-STU81
Study First Received:	November 14, 2008
Results First Received:	August 30, 2010
Last Updated:	November 23, 2010
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Hemangioma
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on February 09, 2012