search
Back to results

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

Primary Purpose

Cherry Angioma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electrodessication
Pulsed dye laser (PDL)
potassium titanyl phosphate (KTP)
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cherry Angioma

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

electrodessication (ED)

pulsed dye laser (PDL)

potassium titanyl phosphate (KTP) laser

Arm Description

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.

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.

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.

Outcomes

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
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).

Secondary Outcome Measures

Full Information

First Posted
November 14, 2008
Last Updated
February 18, 2015
Sponsor
Northwestern University
search

1. Study Identification

Unique Protocol Identification Number
NCT00791908
Brief Title
Comparison of Electrodessication, Potassium Titanyl Phosphate (KTP) Laser and Pulsed Dye Laser for Treatment of Cherry Angiomata
Official Title
Comparison of Electrodessication, Potassium Titanyl Phosphate (KTP) Laser and Pulsed Dye Laser for Treatment of Cherry Angiomata
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cherry Angioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
electrodessication (ED)
Arm Type
Experimental
Arm Description
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.
Arm Title
pulsed dye laser (PDL)
Arm Type
Experimental
Arm Description
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.
Arm Title
potassium titanyl phosphate (KTP) laser
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Electrodessication
Intervention Description
Treatment applied to a third of the torso at each study visit.
Intervention Type
Procedure
Intervention Name(s)
Pulsed dye laser (PDL)
Intervention Description
Laser treatment applied to a third of the torso at each study visit.
Intervention Type
Procedure
Intervention Name(s)
potassium titanyl phosphate (KTP)
Intervention Description
Laser treatment applied to a third of the torso at each study visit.
Primary Outcome Measure Information:
Title
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
Description
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).
Time Frame
Baseline and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murad Alam, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20083690
Citation
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. doi: 10.1001/archdermatol.2009.318.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs