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Fractional Laser and Ultrasound for Striae Distensae

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University
ClinicalTrials.gov Identifier:
NCT01186848
First received: August 19, 2010
Last updated: December 17, 2013
Last verified: December 2013
Results First Received: September 3, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Stretch Marks
Interventions: Device: Combination treatment
Device: 1550-nm erbium-doped fractionated laser

  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
Recruitment period took place over approximately 6 months at an urban academic hospital.

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 Receiving Split Body Treatment

The unit of randomization was the individual side of a body within each subject to receive either 1550-nm erbium-doped fractionated laser treatment or the combination of the laser and ultrasound treatment for the treatment of striae.

Each side of thigh (or abdomen) was randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side and the contralateral side received micro-focused ultrasound treatment and 1550nm-fractionated laser alternatively every 2 weeks for a total of 4 treatments with site-match control area of baseline striae on each side.


Participant Flow:   Overall Study
    Subjects Receiving Split Body Treatment  
STARTED     30  
COMPLETED     22  
NOT COMPLETED     8  
Lost to Follow-up                 4  
Withdrawal by Subject                 2  
Adverse Event                 2  



  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.
No text entered.

Reporting Groups
  Description
Subjects Receiving Split Body Treatment

The unit of randomization was the individual side of a body within each subject to receive either 1550-nm erbium-doped fractionated laser treatment or the combination of the laser and ultrasound treatment for the treatment of striae.

Each side of thigh (or abdomen) was randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side and the contralateral side received micro-focused ultrasound treatment and 1550nm-fractionated laser alternatively every 2 weeks for a total of 4 treatments with site-match control area of baseline striae on each side.


Baseline Measures
    Subjects Receiving Split Body Treatment  
Number of Participants  
[units: participants]
  30  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     30  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  36  ± 8.2  
Gender  
[units: participants]
 
Female     28  
Male     2  
Region of Enrollment  
[units: participants]
 
United States     30  



  Outcome Measures

1.  Primary:   Live-rater by Two Blinded Dermatologists   [ Time Frame: week 10 ]


  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
No text entered.


  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: NCT01186848     History of Changes
Other Study ID Numbers: STU34376
Study First Received: August 19, 2010
Results First Received: September 3, 2013
Last Updated: December 17, 2013
Health Authority: United States:Institutional Reveiw Board