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Completed

NCT Number: NCT03377231

Prevention and Treatment of Stretch Marks With Stratamark™

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

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Key information

Conditions

Stretch Mark Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations Striae Distensae

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stratamark®

Device

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

Primary outcomes

  1. Product efficacy in prevention of stretch marks

    Time frame: 5 months

    Investigator-assessed prevalence of stretch marks in the patients treated with Stratamark vs. a literature-based control group.

    Measurement tool: dichotomous scale for the occurrence of stretch marks (0 no stretch marks - 1 appearance of stretch marks).

  2. Product efficacy in treatment of stretch marks

    Time frame: 6 months

    Investigator-assessed improvement in stretch marks severity of patients treated with Stratamark from baseline to last assessment.

    Measurement tool: likert scale for stretch marks severity (0 to 6 - 0 being no stretch marks and 6 being severe).

Secondary outcomes

  1. Severity of stretch marks developed in prevention

    Time frame: 5 months

    Investigator-assessed severity of stretch marks developed in prevention patients.

    Measurement tool: likert scale for stretch marks severity (0 to 6 - 0 being no stretch marks and 6 being severe).

  2. Patient product evaluation in prevention of stretch marks

    Time frame: 5 months

    Patient-perceived product efficacy, tolerability, ease of use and feel on skin at trial completion.

    Measurement tool: likert scale for product evaluation (0 to 4 - 0 being unsatisfactory and 4 being excellent).

  3. Product efficacy in treatment of stretch marks

    Time frame: 6 months

    Investigator-assessed improvement in stretch marks color of patients treated with Stratamark from baseline to last assessment.

    Measurement tool: likert scale for stretch marks color assessment (-4 to +4 - -4 being stark white compared to surrounding skin and +4 being purple).

    0 being normal skin color, is considered to be the optimal value.

  4. Product efficacy in treatment of stretch marks

    Time frame: 6 months

    Investigator-assessed improvement in stretch marks pruritus of patients treated with Stratamark from baseline to last assessment.

    Measurement tool: likert scale for stretch marks pruritus assessment (0-10 - 0 being no pruritus and 10 being worst possible pruritus).

  5. Patient product evaluation in treatment of stretch marks

    Time frame: 6 months

    Patient-perceived product efficacy, tolerability, ease of use and feeling on skin at trial completion.

    Measurement tool: likert scale for product evaluation (0 to 4 - 0 being unsatisfactory and 4 being excellent).

  6. Patient evaluation of stretch marks in treatment

    Time frame: 6 months

    Patient-perceived change in color and noticeability of stretch marks at trial completion.

    Measurement tool: likert scale for stretch marks patient evaluation (-4 to +4 - -4 being much worse and +4 being cleared).

Sponsors and collaborators

Lead sponsor

Stratpharma AG

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 19, 2017
Registry last updated
Dec 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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