Fractional Laser and Ultrasound for Striae Distensae
|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: NCT01186848|
Recruitment Status : Completed
First Posted : August 23, 2010
Results First Posted : February 3, 2014
Last Update Posted : February 3, 2014
This was a prospective randomized controlled study comparing the efficacy of micro-focused ultrasound when used in conjunction with 1550-nm erbium-doped fractionated laser versus 1550-nm erbium-doped fractionated laser alone for treatment of striae distensae(stretch marks).
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.
The primary outcome measure by two dermatologists blindly compared the two areas of striae distensae on each side from live subjects using a questionnaire and quartile rating scale on the final follow-up visit.
This study was a pilot study designed to determine the feasibility of these procedures.
|Condition or disease||Intervention/treatment||Phase|
|Stretch Marks||Device: Combination treatment Device: 1550-nm erbium-doped fractionated laser||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Comparison of Fractional Photothermolysis Alone Versus Fractional Photothermolysis Plus Intense Focused Ultrasound for Treatment of Striae Distensae: A Prospective Randomized Control Trial.|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
|Active Comparator: 1550-nm erbium-doped fractionated laser||
Device: 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.
Active Comparator: Combination treatment
"micro-focused ultrasound" and "1550nm-fractionated laser"
Device: Combination treatment
The contralateral side received the combination of 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.
- Live-rater by Two Blinded Dermatologists [ Time Frame: week 10 ]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".
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01186848
|United States, Illinois|
|Northwestern University Department of Dermatology|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Murad Alam, MD||Northwestern University|