ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 42 of 201 for:    hemangioma

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Subjects No text entered.

Participant Flow:   Overall Study
    Subjects
STARTED   15 
COMPLETED   15 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Subjects No text entered.

Baseline Measures
   Subjects 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   15 
>=65 years   0 
Age 
[Units: Years]
Mean (Full Range)
 48 
 (21 to 65) 
Gender 
[Units: Participants]
 
Female   5 
Male   10 
Region of Enrollment 
[Units: Participants]
 
United States   15 


  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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
e-mail: m-alam@northwestern.edu


Publications of Results:

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