Prevention and Treatment of Stretch Marks With Stratamark™

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

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

Study Overview

• Status: Completed
• Conditions: Stretch Mark
• Intervention / Treatment: Device: Stratamark®

• Study Type: Interventional
• Enrollment (Actual): 272
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment	Device: Stratamark®; Film-forming dressing for the prevention and treatment of stretch marks.
Experimental: Prevention	Device: Stratamark®; Film-forming dressing for the prevention and treatment of stretch marks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	5 months
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).	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	5 months
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).	5 months
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.	6 months
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).	6 months
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).	6 months
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).	6 months

Collaborators and Investigators

• Sponsor: Stratpharma AG

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2013
• Primary Completion (Actual): May 16, 2016
• Study Completion (Actual): May 16, 2016

Study Registration Dates

• First Submitted: December 8, 2017
• First Submitted That Met QC Criteria: December 13, 2017
• First Posted (Actual): December 19, 2017

Study Record Updates

• Last Update Posted (Actual): December 20, 2017
• Last Update Submitted That Met QC Criteria: December 19, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Pregnancy, Striae gravidarum, Striae distensae, Women's health
• Additional Relevant MeSH Terms: Skin Manifestations; Striae Distensae
• Other Study ID Numbers: SPASK01AU001; SSA/13/WCHN/42 (Other Identifier: WCHN Human Research Ethics Committee)