The primary objective of this study is to determine the effect of Stratacel® wound dressing on cosmetic outcomes following 1064/532nm picosecond laser (Picoway®, Syneron Candela Corp, Wayland, MA, USA) treatment of abdominal striae alba. Secondary objectives include examining the effect of Stratacel® wound dressing on post-laser healing and symptomatology.
Twenty adult subjects with abdominal striae alba will be enrolled. All striae will be treated using the 1064/532nm picosecond laser with designated and standardized settings (Appendix A). The abdominal striae treatment region will then be split across the body vertically with one half randomized to Stratacel® and the other to placebo, clear ultrasound gel (Aquasonic). A blinded study coordinator will apply the products to each randomized half-abdomen immediately following laser treatment. A total of 3 treatments will be completed at 1 month intervals. Blinded-investigator and subject self-assessments will be performed at post-treatment days 2, 5, 7, and 10 after each laser session. Assessments will also be performed 1 and 3 months after the final laser treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
West Dermatology Research Center
San Diego, California, United States
Change in Striae Texture
Assessment of texture Pre treatment and post final treatment using a 5-Point Blinded Investigator Striae Assessment scale
Time frame: Pre-Treatment to 3-months post final treatment.
Change in Striae Color
Assessment of Color Pre treatment and post final treatment
Time frame: Pre-Treatment to 3-months post final treatment.
Change in Striae Size
Assessment of Size Pre treatment and post final treatment using a 5-Point Blinded Investigator Striae Assessment scale.
Time frame: Pre-Treatment to 3-months post final treatment.
Change in Striae Overall Appearance
Assessment of Overall Appearance Pre treatment and post final treatment using a 6-Point Blinded Investigator Striae Assessment scale
Time frame: Pre-Treatment to 3-months post final treatment.
Safety - Post Laser Treatment Adverse Events
erythema, edema, crusting, bruising, hyperpigmentation, hypopigmentation, and scarring
Time frame: days 2, 5, 7, and 10 after each laser session
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