Clinical trial NCT03377231: Prevention and Treatment of Stretch Marks With Stratamark™
Official title: Assessment of Efficacy, Safety and Tolerability of Stratamark® (Innovative Self-drying Silicone Gel) in the Treatment and Prevention of Striae Distensae
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stretch Mark
Keywords: Pregnancy, Striae gravidarum, Striae distensae, Women's health
Lead sponsor: Stratpharma AG
Sponsor class: INDUSTRY
First posted: 2017-12-19
Enrollment: 272
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study involved the use of Stratamark® in prevention and treatment of stretch marks in 2 study arms.
Primary purpose: OTHER

Brief 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


Eligibility criteria: Prevention arm - Inclusion Criteria:

* Healthy pregnant woman (nulliparous or multiparous) entering into their third trimester (26-28 weeks, visit 1)
* Not having striae on their abdomen at the time of trial enrollment

Prevention arm - Exclusion Criteria:

* Any significant medical or surgical conditions
* Current medications liable to interfere with study results or change the skin's response to therapy

Treatment arm - Inclusion Critera:

• Confirmed SD on their abdomen post-delivery

Treatment arm - Exclusion Criteria:

* Any significant medical or surgical conditions
* Current medications liable to interfere with study results or change the skin's response to therapy

Primary outcomes:
measure: Product efficacy in prevention of stretch marks
timeFrame: 5 months
measure: Product efficacy in treatment of stretch marks
timeFrame: 6 months
Secondary outcomes:
measure: Severity of stretch marks developed in prevention
timeFrame: 5 months
measure: Patient product evaluation in prevention of stretch marks
timeFrame: 5 months
measure: Product efficacy in treatment of stretch marks
timeFrame: 6 months
measure: Product efficacy in treatment of stretch marks
timeFrame: 6 months
measure: Patient product evaluation in treatment of stretch marks
timeFrame: 6 months
measure: Patient evaluation of stretch marks in treatment
timeFrame: 6 months
Other outcomes:
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