Prevention and Treatment of Stretch Marks With Stratamark™

NCT03377231 | Completed Phase 4

• 2 other identifiers: SPASK01AU001SSA/13/WCHN/42
• Study Type: interventional
• Target: 272
• Locations: 0 countries
• Sites: N/A

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

Conditions

Stretch Mark

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Severity of stretch marks developed in prevention

  5 months

• Patient product evaluation in prevention of stretch marks

  5 months

• Product efficacy in treatment of stretch marks

  6 months

• Product efficacy in treatment of stretch marks

  6 months

• Patient product evaluation in treatment of stretch marks

  6 months

Study Arms (2)

Prevention

EXPERIMENTAL

Device: Stratamark®

Treatment

EXPERIMENTAL

Device: Stratamark®

Interventions

Stratamark® DEVICE

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

Prevention; Treatment

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Stratpharma AG: lead

MeSH Terms

Conditions

Striae Distensae

Condition Hierarchy (Ancestors)

Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study involved the use of Stratamark® in prevention and treatment of stretch marks in 2 study arms.

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 19, 2017
• Study Start: July 11, 2013
• Primary Completion: May 16, 2016
• Study Completion: May 16, 2016
• Last Updated: December 20, 2017

Record last verified: 2017-12