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Fractional Laser and Ultrasound for Striae Distensae

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ClinicalTrials.gov Identifier: NCT01186848
Recruitment Status : Completed
First Posted : August 23, 2010
Results First Posted : February 3, 2014
Last Update Posted : February 3, 2014
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Stretch Marks
Interventions Device: Combination treatment
Device: 1550-nm erbium-doped fractionated laser
Enrollment 30
Recruitment Details Recruitment period took place over approximately 6 months at an urban academic hospital.
Pre-assignment Details  
Arm/Group Title Subjects Receiving Split Body Treatment
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 30
Completed 22
Not Completed 8
Reason Not Completed
Lost to Follow-up             4
Withdrawal by Subject             2
Adverse Event             2
Arm/Group Title Subjects Receiving Split Body Treatment
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
30
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
36  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
28
  93.3%
Male
2
   6.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Live-rater by Two Blinded Dermatologists
Hide Description The primary outcome was a blinded rating of the treatment area (Fractional Laser vs. Fractional Laser plus Intense Focused Ultrasound) with the best cosmetic appearance. Two dermatologists blindly evaluated the treated and control areas of each side from live subjects on the final follow up visit (week 10). This was reported as percentages of participants for whom "1550-nm Erbium-doped Fractionated Laser" or "Micro-focused Ultrasound and 1550nm-fractionated Laser" resulted in the "best cosmetic appearance".
Time Frame week 10
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1550-nm Erbium-doped Fractionated Laser Combination Treatment
Hide Arm/Group Description:
1550-nm erbium-doped fractionated laser : 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.
Combination of micro-focused ultrasound and 1550nm-fractionated laser : The treated sites were 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.
Overall Number of Participants Analyzed 22 22
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
77.27
(54.63 to 92.18)
22.73
(7.82 to 45.37)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1550-nm Erbium-doped Fractionated Laser Combination Treatment
Hide Arm/Group Description 1550-nm erbium-doped fractionated laser : 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. Combination of micro-focused ultrasound and 1550nm-fractionated laser : The treated sites were 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.
All-Cause Mortality
1550-nm Erbium-doped Fractionated Laser Combination Treatment
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
1550-nm Erbium-doped Fractionated Laser Combination Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/30 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
1550-nm Erbium-doped Fractionated Laser Combination Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/30 (3.33%)      3/30 (10.00%)    
General disorders     
pain  0/30 (0.00%)  0 1/30 (3.33%)  1
numbness  0/30 (0.00%)  0 1/30 (3.33%)  1
hyperpigmentation  1/30 (3.33%)  1 1/30 (3.33%)  1
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Murad Alam
Organization: Northwestern University
Phone: 312-695-4761
EMail: m-alam@northwestern.edu
Layout table for additonal information
Responsible Party: Murad Alam, Northwestern University
ClinicalTrials.gov Identifier: NCT01186848     History of Changes
Other Study ID Numbers: STU34376
First Submitted: August 19, 2010
First Posted: August 23, 2010
Results First Submitted: September 3, 2013
Results First Posted: February 3, 2014
Last Update Posted: February 3, 2014