Stretch Marks on Abdomen
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03750422|
Recruitment Status : Unknown
Verified May 2019 by Isabella Guiha, Goldman, Butterwick, Fitzpatrick and Groff.
Recruitment status was: Active, not recruiting
First Posted : November 23, 2018
Last Update Posted : May 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Striae; Albicantes||Device: Picoway Other: Stratacel Other: Aquasonic||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||double-blinded, randomized split-body study|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||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.|
|Official Title:||A Split-body, Double-blinded, Placebo-controlled Trial of Stratacel® Wound Dressing After Laser Treatment of Striae Alba|
|Actual Study Start Date :||July 1, 2018|
|Estimated Primary Completion Date :||November 30, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Active Comparator: Stratacel
medical grade silicone gel following Picoway Laser treatment
1064/532nm picosecond laser
a self-drying, bacteriostatic, transparent silicone gel with anti-inflammatory properties
Sham Comparator: Vehicle
Clear ultrasound gel following Picoway Laser treatment
1064/532nm picosecond laser
clear ultrasound gel
- Change in Striae Texture [ Time Frame: Pre-Treatment to 3-months post final treatment. ]Assessment of texture Pre treatment and post final treatment using a 5-Point Blinded Investigator Striae Assessment scale
- Change in Striae Color [ Time Frame: Pre-Treatment to 3-months post final treatment. ]Assessment of Color Pre treatment and post final treatment
- Change in Striae Size [ Time Frame: Pre-Treatment to 3-months post final treatment. ]Assessment of Size Pre treatment and post final treatment using a 5-Point Blinded Investigator Striae Assessment scale.
- Change in Striae Overall Appearance [ Time Frame: Pre-Treatment to 3-months post final treatment. ]Assessment of Overall Appearance Pre treatment and post final treatment using a 6-Point Blinded Investigator Striae Assessment scale
- Safety - Post Laser Treatment Adverse Events [ Time Frame: days 2, 5, 7, and 10 after each laser session ]erythema, edema, crusting, bruising, hyperpigmentation, hypopigmentation, and scarring
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03750422
|United States, California|
|West Dermatology Research Center|
|San Diego, California, United States, 92121|
|Principal Investigator:||Mitchel P Goldman, MD||Cosmetic Laser Dermatology|