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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: November 5, 2012
Last verified: November 2012
History of Changes
  Purpose

This is 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) will be randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side and the contralateral side will receive 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 will blindly compare the two areas of striae distensae on each side from live subjects using a questionnaire and quartile rating scale on the final follow up day.

This study is a pilot study designed to determine the feasibility of these procedures.


Condition Intervention
Stretch Marks
 Device: micro-focused ultrasound and 1550nm-fractionated laser
Device: 1550-nm erbium-doped fractionated laser

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Fractional Photothermolysis Alone Versus Fractional Photothermolysis Plus Intense Focused Ultrasound for Treatment of Striae Distensae: A Prospective Randomized Control Trial.

Resource links provided by NLM:

Drug Information available for: Erbium
U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 30
Study Start Date: August 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1550-nm erbium-doped fractionated laser Device: 1550-nm erbium-doped fractionated laser
Each side of thigh (or abdomen) will be randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side.
Active Comparator: micro-focused ultrasound and 1550nm-fractionated laser Device: micro-focused ultrasound and 1550nm-fractionated laser
The treated sites will be randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side and the contralateral side will receive 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.

Detailed Description:

The secondary outcomes are a qualitative measurements of the mean striae width in the treatment area before(week0) and after treatment(week10) and subject satisfaction will be determined by a satisfaction questionnaire.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01186848

Locations
United States, Illinois
Northwestern University Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Murad Alam, MD Northwestern University
  More Information

No publications provided

Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology - Head and Neck Surgery and Surgery-Organ Transplantation, Northwestern University
ClinicalTrials.gov Identifier: NCT01186848     History of Changes
Other Study ID Numbers: STU34376
Study First Received: August 19, 2010
Last Updated: November 5, 2012
Health Authority: United States:Institutional Reveiw Board

Keywords provided by Northwestern University:
Stretch marks
Striae distensae

Additional relevant MeSH terms:
Striae Distensae
Skin Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013