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Prevention and Treatment of Stretch Marks With Stratamark™

NCT ID: NCT03377231

Last Updated: 2017-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

272 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-11

Study Completion Date

2016-05-16

Brief Summary

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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

Detailed Description

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Conditions

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Stretch Mark

Keywords

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Pregnancy, Striae gravidarum, Striae distensae, Women's health

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The study involved the use of Stratamark® in prevention and treatment of stretch marks in 2 study arms.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Prevention

Group Type EXPERIMENTAL

Stratamark®

Intervention Type DEVICE

Film-forming dressing for the prevention and treatment of stretch marks.

Treatment

Group Type EXPERIMENTAL

Stratamark®

Intervention Type DEVICE

Film-forming dressing for the prevention and treatment of stretch marks.

Interventions

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Stratamark®

Film-forming dressing for the prevention and treatment of stretch marks.

Intervention Type DEVICE

Eligibility Criteria

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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

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


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

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Stratpharma AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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SSA/13/WCHN/42

Identifier Type: OTHER

Identifier Source: secondary_id

SPASK01AU001

Identifier Type: -

Identifier Source: org_study_id