Stretch MarkPhase 4NCT03377231
Prevention and Treatment of Stretch Marks With Stratamark™
A Phase 4 study testing Stratamark® in people with Stretch Mark, run by Stratpharma AG.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stretch Mark
- What is being tested?
- Stratamark®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- No sites listed yet
- Study dates
- 11 Jul 2013to 16 May 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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
About this study
Official title: 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
- Conditions
- Stretch Mark
- Being tested
- Stratamark®
- Keywords
- Pregnancy, Striae gravidarum, Striae distensae, Women's health
- Medical subject headings
- Striae Distensae
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stratamark®Device
Film-forming dressing for the prevention and treatment of stretch marks.
| Study group | Role | What they receive |
|---|---|---|
| Prevention | Experimental | Not described Receives: Device: Stratamark® |
| Treatment | Experimental | Not described Receives: Device: Stratamark® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 6 months
Secondary outcomes (6)
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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start11 Jul 2013
- Primary completion16 May 2016
- Study completion16 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stretch MarkStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study involved the use of Stratamark® in prevention and treatment of stretch marks in 2 study arms.
- Masking
- None (open label)
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stratpharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03377231
- Sponsor's protocol ID
- SPASK01AU001
- Other IDs
- SSA/13/WCHN/42
- Status last verified
- Dec 2017
- First submitted
- 8 Dec 2017
- Last updated
- 20 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Efficacy, Safety and Tolerability of Stratamark® (Innovative Self-drying Silicone Gel) in the Treatment and Prevention of Striae Distensae
- ClinicalTrials.gov ID
- NCT03377231
- Acronym / sponsor ID
- SPASK01AU001
- Conditions
- Stretch Mark
- Keywords
- Pregnancy, Striae gravidarum, Striae distensae, Women's health
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Stratpharma AGIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2013 (actual)
- Primary completion
- 16 May 2016 (actual)
- Study completion
- 16 May 2016 (actual)
- First posted
- 19 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study involved the use of Stratamark® in prevention and treatment of stretch marks in 2 study arms.
| Arm | Type | Receives |
|---|---|---|
| Prevention | Experimental | Device: Stratamark® |
| Treatment | Experimental | Device: Stratamark® |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stratamark®Film-forming dressing for the prevention and treatment of stretch marks. | Device | Prevention, Treatment |
Primary outcome
Product efficacy in prevention of stretch marks
Time frame: 5 months
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
Time frame: 6 months
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 secondary outcomes
Severity of stretch marks developed in prevention
Time frame: 5 months
Patient product evaluation in prevention of stretch marks
Time frame: 5 months
Product efficacy in treatment of stretch marks
Time frame: 6 months
Product efficacy in treatment of stretch marks
Time frame: 6 months
Patient product evaluation in treatment of stretch marks
Time frame: 6 months
Patient evaluation of stretch marks in treatment
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Stratamark® in people with Stretch Mark, run by Stratpharma AG.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Product efficacy in prevention of stretch marks (time frame: 5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2017.