Fractional Laser and Ultrasound for Striae Distensae

Study Overview
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Brief Summary
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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.

Detailed Description
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The secondary outcomes were qualitative measurements of the mean striae width in the treatment area before(week0) and after treatment(week10) and subject satisfaction was determined by a satisfaction questionnaire.

Official Title
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Comparison of Fractional Photothermolysis Alone Versus Fractional Photothermolysis Plus Intense Focused Ultrasound for Treatment of Striae Distensae: A Prospective Randomized Control Trial.

Conditions
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Stretch Marks

Intervention / Treatment
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* Device: Combination treatment
* Device: 1550-nm erbium-doped fractionated laser


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-60 years old male and female subjects with striae distensae on both thighs or both sides of the abdomen. Subjects are in good health. Subjects are willing, have the ability to understand and provide informed consent, and are able to communicate with the investigator. Subjects should be within a 20 lb range of their starting weight during in the study period. Exclusion Criteria: Pregnant or lactating Subjects who are unable to understand the protocol or give informed consent. Subjects currently under treatment with corticosteroids for any medical problems or subjects who discontinued treatment less than 2 months prior to consent. Subjects who have had medical e.g usage of oral or topical retinoids, laser or surgical treatment for striae distensae within the last year. Subjects who have active skin disease or skin infection in the treatment area. Subjects who are allergic to lidocaine or prilocaine. Subjects who have a history of abnormal scarring.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1550-nm erbium-doped fractionated laser<br> | Device: 1550-nm erbium-doped fractionated laser<br>* 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.<br>|
| Active Comparator: Combination treatment<br>micro-focused ultrasound and 1550nm-fractionated laser | Device: Combination treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live-rater by Two Blinded Dermatologists | 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. | week 10 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stretch marks, Striae distensae