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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Cherry Angioma
Interventions Procedure: Electrodessication
Procedure: Pulsed dye laser (PDL)
Procedure: potassium titanyl phosphate (KTP)
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Subjects
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 15
Completed 15
Not Completed 0
Arm/Group Title Subjects
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
<=18 years
0
   0.0%
Between 18 and 65 years
15
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants
48
(21 to 65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
5
  33.3%
Male
10
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants
15
1.Primary Outcome
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Electrodesiccation (ED) KTP Laser Pulsed-dye Laser (PDL)
Hide Arm/Group Description:
Laser treatment applied to a third of the torso at each study visit.
Laser treatment applied to a third of the torso at each study visit.
Laser treatment applied to a third of the torso at each study visit.
Overall Number of Participants Analyzed 15 15 15
Mean (Full Range)
Unit of Measure: Units on a scale
Color of Cherry Angiomata
5.27
(0 to 10)
4.99
(0 to 10)
5.19
(0 to 10)
Texture of Cherry Angiomata
4.24
(0 to 10)
3.42
(0 to 10)
3.24
(0 to 10)
Size of Cherry Angiomata
3.40
(0 to 10)
3.44
(0 to 10)
3.31
(0 to 10)
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Electrodesiccation (ED) KTP Laser Pulsed-dye Laser (PDL)
Hide Arm/Group Description Laser treatment applied to a third of the torso at each study visit. Laser treatment applied to a third of the torso at each study visit. Laser treatment applied to a third of the torso at each study visit.
All-Cause Mortality
Electrodesiccation (ED) KTP Laser Pulsed-dye Laser (PDL)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Electrodesiccation (ED) KTP Laser Pulsed-dye Laser (PDL)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Electrodesiccation (ED) KTP Laser Pulsed-dye Laser (PDL)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/15 (0.00%)   0/15 (0.00%)   0/15 (0.00%) 
Absence of a cost analysis; all the participants were white; only one set of parameters (ie, for lasers, pulse duration and fluence; and for electrodesiccation, energy level) was used for treatment with each modality.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Murad Alam, MD
Organization: Northwestern University
Phone: 312-695-6785
Responsible Party: Murad Alam, Northwestern University
ClinicalTrials.gov Identifier: NCT00791908     History of Changes
Other Study ID Numbers: MA-STU81
First Submitted: November 14, 2008
First Posted: November 17, 2008
Results First Submitted: August 30, 2010
Results First Posted: December 21, 2010
Last Update Posted: March 6, 2015