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NCT03377231

Prevention and Treatment of Stretch Marks With Stratamark™

Completed Phase 4 Last updated 20 December 2017
What this trial tests

Phase 4 trial testing Stratamark® in Stretch Mark in 272 participants. Completed in 16 May 2016.

Timeline
11 July 2013
Primary endpoint
16 May 2016
16 May 2016

Quick facts

Lead sponsorStratpharma AG
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposeother
Enrollment272
Start date11 July 2013
Primary completion16 May 2016
Estimated completion16 May 2016

Drugs / interventions tested

Conditions studied

Sponsor

Stratpharma AG — full company profile →

Who can join

18 and older, female only, with Stretch Mark. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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