A Phase 4 interventional study of Stratamark® in Stretch Mark, sponsored by Stratpharma AG. Completed. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-20.
Sponsored by Stratpharma AG · Phase 4, Interventional, and Other
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
44 studies on the registry are indexed under Striae Distensae; 7 are open to participants now.
This study's enrollment of 272 is above the median of 30 across 43 interventional studies indexed under Striae Distensae.
Browse Striae Distensae studies →Stratpharma AG is the lead sponsor of 12 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Prevention arm - Inclusion Criteria:
Prevention arm - Exclusion Criteria:
Treatment arm - Inclusion Critera:
Treatment arm - Exclusion Criteria:
Device: Stratamark®
Device: Stratamark®
Film-forming dressing for the prevention and treatment of stretch marks.
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).
Time frame: 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).
Time frame: 6 months
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).
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 6 months
No study locations are listed for this record.
Ran from Jul 2013 to primary completion in May 2016, 34 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Stratpharma AG