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

August 19, 2010
December 17, 2013
August 2010
June 2011   (final data collection date for primary outcome measure)
Live-rater by Two Blinded Dermatologists [ Time Frame: week 10 ] [ Designated as safety issue: No ]
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".
Live-rater by two blinded dermatologists [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Two dermatologists will blindly evaluate the treated and control areas of each side. They will also compare the treated areas of both sides from live subjects on the final follow up visit (week 10) using the live rating questionnaire and quartile rating scale.
Complete list of historical versions of study NCT01186848 on ClinicalTrials.gov Archive Site
Not Provided
mean striae width [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Comparison of the objective measurement of the mean striae width in the 10x10cm treated areas of each before treatment (week 0) and at the follow up visit (week 10).
Not Provided
Not Provided
 
Fractional Laser and Ultrasound for Striae Distensae
Comparison of Fractional Photothermolysis Alone Versus Fractional Photothermolysis Plus Intense Focused Ultrasound for Treatment of Striae Distensae: A Prospective Randomized Control Trial.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Stretch Marks
  • 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.
  • 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: 1550-nm erbium-doped fractionated laser
    Intervention: Device: 1550-nm erbium-doped fractionated laser
  • Active Comparator: Combination treatment
    "micro-focused ultrasound" and "1550nm-fractionated laser"
    Intervention: Device: Combination treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01186848
STU34376
Yes
Murad Alam, Northwestern University
Northwestern University
Not Provided
Principal Investigator: Murad Alam, MD Northwestern University
Northwestern University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP