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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:
Information provided by (Responsible Party):
Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:
NCT01285947
First received: January 27, 2011
Last updated: May 22, 2014
Last verified: May 2014
Results First Received: September 3, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject)
Condition: Pain Experience During Commonly Used Dermatologic Energy Devices.
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  
Number of Participants  
[units: participants]
  10     10     20  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     10     10     20  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     10     10     20  
Male     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


No publications provided


Responsible Party: Murad Alam, Northwestern University
ClinicalTrials.gov Identifier: NCT01285947     History of Changes
Other Study ID Numbers: STU 40788
Study First Received: January 27, 2011
Results First Received: September 3, 2013
Last Updated: May 22, 2014
Health Authority: United States: Institutional Review Board