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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stratacel | Active Comparator | medical grade silicone gel following Picoway Laser treatment |
|
| Vehicle | Sham Comparator | Clear ultrasound gel following Picoway Laser treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Picoway | Device | 1064/532nm picosecond laser |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Striae Texture | Assessment of texture Pre treatment and post final treatment using a 5-Point Blinded Investigator Striae Assessment scale | Pre-Treatment to 3-months post final treatment. |
| Change in Striae Color | Assessment of Color Pre treatment and post final treatment | 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. | 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 | Pre-Treatment to 3-months post final treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - Post Laser Treatment Adverse Events | erythema, edema, crusting, bruising, hyperpigmentation, hypopigmentation, and scarring | days 2, 5, 7, and 10 after each laser session |
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Inclusion Criteria:
1. Having no uterus 2. No menses for at least 12 months.
Or:
Women of childbearing potential must agree to use an effective method of birth control during the course of the study. All systemic birth control measures must be in consistent use for at least 30 days prior to study enrollment participation. Expectable forms of birth control below:
Exclusion Criteria:
1. Pregnancy, planned pregnancy during the course of the study or currently breast feeding.
2. Projected significant fluctuations in weight during the course of the study or within the last 6 months, per investigator discretion.
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| Name | Affiliation | Role |
|---|---|---|
| Mitchel P Goldman, MD | Cosmetic Laser Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Dermatology Research Center | San Diego | California | 92121 | United States |
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| ID | Term |
|---|---|
| D057896 | Striae Distensae |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C071627 | Aquasonic |
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double-blinded, randomized split-body study
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Subjects are provided with de-identified tubes of both study product and vehicle then instructed on which de-identified product is to be used for aftercare on which side of the abdomen.
| Stratacel |
| Other |
a self-drying, bacteriostatic, transparent silicone gel with anti-inflammatory properties |
|
| Aquasonic | Other | clear ultrasound gel |
|