Prevention and Treatment of Stretch Marks With Stratamark™

Stratpharma

Status and phase: Completed; Phase 4

Conditions: Stretch Mark

Treatments: Device: Stratamark®

Study type: Interventional

Funder types: Industry

Identifiers

NCT03377231

SSA/13/WCHN/42 (Other Identifier)

SPASK01AU001

Details and patient eligibility

About

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

Enrollment: 272 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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272 participants in 2 patient groups

Prevention

Experimental group

Treatment:

Device: Stratamark®

Treatment

Experimental group

Treatment:

Device: Stratamark®