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Fractional Laser and Ultrasound for Striae Distensae

Primary Purpose

Stretch Marks

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Combination treatment
1550-nm erbium-doped fractionated laser
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stretch Marks focused on measuring Stretch marks, Striae distensae

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Northwestern University Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1550-nm erbium-doped fractionated laser

Combination treatment

Arm Description

"micro-focused ultrasound" and "1550nm-fractionated laser"

Outcomes

Primary Outcome Measures

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".

Secondary Outcome Measures

Full Information

First Posted
August 19, 2010
Last Updated
December 1, 2021
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT01186848
Brief Title
Fractional Laser and Ultrasound for Striae Distensae
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 Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stretch Marks
Keywords
Stretch marks, Striae distensae

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1550-nm erbium-doped fractionated laser
Arm Type
Active Comparator
Arm Title
Combination treatment
Arm Type
Active Comparator
Arm Description
"micro-focused ultrasound" and "1550nm-fractionated laser"
Intervention Type
Device
Intervention Name(s)
Combination treatment
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
1550-nm erbium-doped fractionated laser
Intervention Description
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.
Primary Outcome Measure Information:
Title
Live-rater by Two Blinded Dermatologists
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murad Alam, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Department of Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

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Fractional Laser and Ultrasound for Striae Distensae

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