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
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
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
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
Learn more about this trial
Prevention and Treatment of Stretch Marks With Stratamark™
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