NCT03750422|UnknownFDA Device
Stretch Marks on Abdomen
A Split-body, Double-blinded, Placebo-controlled Trial of Stratacel® Wound Dressing After Laser Treatment of Striae Alba
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A Split-body, Double-blinded, Placebo-controlled Trial of Stratacel® Wound Dressing After Laser Treatment of Striae Alba
Sponsor study identifier
interventional
20
1 country
1
Study Start
July 1, 2018
Actual (reported)Primary Completion
November 30, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 1, 2018
Actual (reported)November 8, 2018
Actual (reported)November 23, 2018
Actual (reported)November 30, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Safety - Post Laser Treatment Adverse Events
days 2, 5, 7, and 10 after each laser session
medical grade silicone gel following Picoway Laser treatment
Clear ultrasound gel following Picoway Laser treatment
1064/532nm picosecond laser
a self-drying, bacteriostatic, transparent silicone gel with anti-inflammatory properties
West Dermatology Research Center
San Diego, California, 92121, United States
Mitchel P Goldman, MD
Cosmetic Laser Dermatology
20 participants (actual enrollment reported by the registry).
First Submitted
November 8, 2018
First Posted
November 23, 2018
Study Start
clear ultrasound gel
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
July 1, 2018
Actual (reported)Primary Completion
November 30, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 10, 2019
Record last verified: 2019-05
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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