NCT03750422

Stretch Marks on Abdomen

A Split-body, Double-blinded, Placebo-controlled Trial of Stratacel® Wound Dressing After Laser Treatment of Striae Alba

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Goldman, Butterwick, Fitzpatrick and Groff · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Striae; Albicantes

Interventions

Type	Name	Description
DEVICE	Picoway	1064/532nm picosecond laser
OTHER	Stratacel	a self-drying, bacteriostatic, transparent silicone gel with anti-inflammatory properties
OTHER	Aquasonic	clear ultrasound gel

Timeline

• Start date: 2018-07-01
• Primary completion: 2019-11-30
• Completion: 2019-12-31
• First posted: 2018-11-23
• Last updated: 2019-05-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study