Fractional Laser and Ultrasound for Striae Distensae

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.

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.

• 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.
• 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: 1550-nm erbium-doped fractionated laser
  Intervention: Device: 1550-nm erbium-doped fractionated laser
• Active Comparator: micro-focused ultrasound and 1550nm-fractionated laser
  Intervention: Device: micro-focused ultrasound and 1550nm-fractionated laser

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.