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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03377231
Other study ID # SPASK01AU001
Secondary ID SSA/13/WCHN/42
Status Completed
Phase Phase 4
First received December 8, 2017
Last updated December 19, 2017
Start date July 11, 2013
Est. completion date May 16, 2016

Study information

Verified date December 2017
Source Stratpharma AG
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 272
Est. completion date May 16, 2016
Est. primary completion date May 16, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Device:
Stratamark®
Film-forming dressing for the prevention and treatment of stretch marks.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Stratpharma AG

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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