Clinical trial NCT01186848: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stretch Marks
Keywords: Stretch marks
Striae distensae
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2010-08-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Live-rater by Two Blinded Dermatologists
timeFrame: week 10
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Department of Dermatology
state: Illinois
Study officials:
affiliation: Northwestern University
name: Murad Alam, MD
role: PRINCIPAL_INVESTIGATOR
References: