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Comparing the Pain Experience Between Patients Who Have and Who Have Not Undergone Dermatologic Procedures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01285947
First Posted: January 28, 2011
Last Update Posted: February 1, 2017
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.
Information provided by (Responsible Party):
Murad Alam, Northwestern University
Results First Submitted: September 3, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant)
Condition: Pain
Interventions: Device: Thermage
Other: Needle Application
Device: VBeam Laser
Device: Ulthera

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Naive Subjects Subjects who have not previously undergone energy-based dermatologic procedures in the past.
Non-Naive Subjects Subjects who have previously undergone energy-based dermatologic procedures in the past.

Participant Flow:   Overall Study
    Naive Subjects   Non-Naive Subjects
STARTED   10   10 
COMPLETED   10   10 
NOT COMPLETED   0   0 



  Baseline Characteristics
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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.
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Reporting Groups
  Description
Naive Subjects Subjects who have not previously undergone energy-based dermatologic procedures in the past.
Non-Naive Subjects Subjects who have previously undergone energy-based dermatologic procedures in the past.
Total Total of all reporting groups

Baseline Measures
   Naive Subjects   Non-Naive Subjects   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   20 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      10 100.0%      10 100.0%      20 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Gender 
[Units: Participants]
Count of Participants
     
Female      10 100.0%      10 100.0%      20 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   10   10   20 


  Outcome Measures

1.  Primary:   Pain Rated by Subjects   [ Time Frame: 3 hours for all treatments in one visit ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Murad Alam
Organization: Northwestern University
phone: 312-695-4761
e-mail: m-alam@northwestern.edu



Responsible Party: Murad Alam, Northwestern University
ClinicalTrials.gov Identifier: NCT01285947     History of Changes
Other Study ID Numbers: STU 40788
First Submitted: January 27, 2011
First Posted: January 28, 2011
Results First Submitted: September 3, 2013
Results First Posted: February 5, 2014
Last Update Posted: February 1, 2017