NCT03377231

Prevention and Treatment of Stretch Marks With Stratamark™

Assessment of Efficacy, Safety and Tolerability of Stratamark® (Innovative Self-drying Silicone Gel) in the Treatment and Prevention of Striae Distensae

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 272 (actual)
• Sponsor: Stratpharma AG · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

Stretch marks (striae distensae) are a form of scarring that is a natural result of pregnancy, obesity and in some instances occur due to puberty or steroid use. For some people, the stretch marks do not cause a problem, but in many circumstances they can cause physical symptoms such as itchiness, tenderness and pain. For many people stretch marks are also embarrassing and can have detrimental effects on a patient's mood and self-esteem. Stretch marks that result from pregnancy most commonly occur on the abdomen, breasts and thighs. Topical silicone gel was developed nearly thirty years ago to be used in the treatment of widespread hypertrophic scars (abnormal scars, which may be red or raised/depressed itchy or painful). Since this time it has been used successfully on most scar types. . Since stretch marks are a form of scarring it is thought that topical silicone gel may be helpful for this scar type also. Stratamark™ has been developed using different forms of silicone polymers, in a gel format, that dries to form a very thin and flexible silicone gel sheet making it a convenient therapy for the treatment and prevention of stretch marks. The aim of this clinical research study is to prove or disprove the efficacy, safety and tolerability of Stratamark™ in the prevention and treatment of stretch marks. In addition, the knowledge gained from this study may be of benefit to many future patients

Conditions

• Stretch Mark

Interventions

Type	Name	Description
DEVICE	Stratamark®	Film-forming dressing for the prevention and treatment of stretch marks.

Timeline

• Start date: 2013-07-11
• Primary completion: 2016-05-16
• Completion: 2016-05-16
• First posted: 2017-12-19
• Last updated: 2017-12-20