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Prevention and Treatment of Stretch Marks With Stratamark™

Primary Purpose

Stretch Mark

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Stratamark®
Sponsored by
Stratpharma AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stretch Mark focused on measuring Pregnancy, Striae gravidarum, Striae distensae, Women's health

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Prevention

    Treatment

    Arm Description

    Outcomes

    Primary Outcome Measures

    Product efficacy in prevention of stretch marks
    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).
    Product efficacy in treatment of stretch marks
    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 Outcome Measures

    Severity of stretch marks developed in prevention
    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).
    Patient product evaluation in prevention of stretch marks
    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).
    Product efficacy in treatment of stretch marks
    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.
    Product efficacy in treatment of stretch marks
    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).
    Patient product evaluation in treatment of stretch marks
    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).
    Patient evaluation of stretch marks in treatment
    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).

    Full Information

    First Posted
    December 8, 2017
    Last Updated
    December 19, 2017
    Sponsor
    Stratpharma AG
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03377231
    Brief Title
    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

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 11, 2013 (Actual)
    Primary Completion Date
    May 16, 2016 (Actual)
    Study Completion Date
    May 16, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Stratpharma AG

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stretch Mark
    Keywords
    Pregnancy, Striae gravidarum, Striae distensae, Women's health

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    The study involved the use of Stratamark® in prevention and treatment of stretch marks in 2 study arms.
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    272 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Prevention
    Arm Type
    Experimental
    Arm Title
    Treatment
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    Stratamark®
    Intervention Description
    Film-forming dressing for the prevention and treatment of stretch marks.
    Primary Outcome Measure Information:
    Title
    Product efficacy in prevention of stretch marks
    Description
    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).
    Time Frame
    5 months
    Title
    Product efficacy in treatment of stretch marks
    Description
    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).
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Severity of stretch marks developed in prevention
    Description
    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).
    Time Frame
    5 months
    Title
    Patient product evaluation in prevention of stretch marks
    Description
    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).
    Time Frame
    5 months
    Title
    Product efficacy in treatment of stretch marks
    Description
    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.
    Time Frame
    6 months
    Title
    Product efficacy in treatment of stretch marks
    Description
    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).
    Time Frame
    6 months
    Title
    Patient product evaluation in treatment of stretch marks
    Description
    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).
    Time Frame
    6 months
    Title
    Patient evaluation of stretch marks in treatment
    Description
    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).
    Time Frame
    6 months

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Pregnant women
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

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    Prevention and Treatment of Stretch Marks With Stratamark™

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