Hypertrophic CicatrixPhase 4NCT01004536
An Investigator-blind Multi-center Prospective Study for the Efficacy and Safety of Silicon Gel (Dermatix)
A Phase 4 study testing silicone gel and no treatment in people with Hypertrophic Cicatrix, run by Samsung Medical Center at 3 sites in South Korea.
Trial summary
Silicone gel is a self-drying silicone polymer that forms thin film after application onto the skin. Because silicone film is a medical device, silicone gel is also regarded as a medical device. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Hypertrophic Cicatrix
- What is being tested?
- silicone gel and no treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Oct 2010to Feb 2011
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant female of 20-45 in ages equal to or beyond 34th of pregnancy
- Those who understand and agree on the trial conditions
Who cannot join
- Keloid (by present and past medical history)
- Secondary infection, and/or dermatitis in and around c/s wound
- Hypersensitivity to the study agent
- Diabetes
- (Pre)eclampsia
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Samsung Medical Center
Seoul, Seoul, 135-710
Kyung-Hee University Medical Center
Seoul, Seoul
Seoul National University Hospital
Seoul, Seoul
About this study
Official title: A Randomized Investigator-blind Multi-center Prospective Study for the Efficacy and Safety of Silicon Gel (Dermatix) in the Prevention of Hypertrophic Scar in Subjects Undergoing Caesarean Section
Silicone gel is a self-drying silicone polymer that forms thin film after application onto the skin. Because silicone film is a medical device, silicone gel is also regarded as a medical device. Silicone gel has been on the market for many years for the management of scar in the phase of treatment as well as in the phase of prevention. In contrast to other methods that are expensive, invasive or inconvenient, silicone gel is convenient, non-invasive and also reasonably priced. However, the number of well-designed clinicial trials for efficacy and safety are not enough to provide robust evidences in making clinical decisions for scar management options. In a prospective, multi-center, investigator-blind randomized half-split study for patients undergoing cesarean sections, the investigators attempt to provide valid information for the efficacy and safety of silicone gel in the prevention phase of scar.
Read the detailed description
Prospective subjects will be enrolled in the trial when eligibility screening and informed consent were made. One day after stitch out for cesarean sections, subjects will be asked to start applying silicone gel as the instruction to the randomly designated half of the wound 2 times a day for 12 weeks. Subjects are asked to make visits on week 4, 8, and 12 for efficacy, safety and compliance evaluations. Obstetricians, dermatologists and medical imaging specialists are involved in the trial for the evaluation of efficacy, safety and compliance. Sample size calculation as well as statistical analysis will be conducted by a designated statistician. Study product will be provided by the manufacturer at no cost and patient visits and relevant lab exams will be conducted free of charge.
- Conditions
- Hypertrophic Cicatrix
- Being tested
- silicone gel, no treatment
- Medical subject headings
- Cicatrix, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silicone gelDevice
Also called Dermatix
twice daily application onto designated half of cesarean section wound for 12 weeks
no treatmentOther
left untreated during the study period
| Study group | Role | What they receive |
|---|---|---|
| no treatment | No intervention | The other half of cesarean section wound that is to be left untreated. Receives: Other: no treatment |
| silicone gel | Experimental | Randomly-designated half of cesarean section wound that is to be subject to application ot silicone gel Receives: Device: silicone gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
summation of scar scores of modified Vancouver Scar Scale
Measured: week 12
Secondary outcomes (4)
summation of scar scores of mVSS 4 and 8 weeks after application
Measured: weeks 4, 8, 12
scar thickness 12 weeks after application
Measured: weeks 4, 8, 12
subjective satisfaction 12 weeks after application (VAS)
Measured: weeks 4, 8, 12
tolerability 4, 8, 12 weeks after application (index3)
Measured: weeks 4, 8, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2009 (estimated)
- Study startOct 2010
- Primary completionFeb 2011 (estimated)
- Study completionFeb 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CicatrixStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Hospital, Kyunghee University Medical Center, Inovail
- Investigators
- Joo-Heung Lee, MD, Study chair, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01004536
- Sponsor's protocol ID
- 2009-08-092
- Status last verified
- Dec 2010
- First submitted
- 29 Oct 2009
- Last updated
- 13 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Investigator-blind Multi-center Prospective Study for the Efficacy and Safety of Silicon Gel (Dermatix) in the Prevention of Hypertrophic Scar in Subjects Undergoing Caesarean Section
- ClinicalTrials.gov ID
- NCT01004536
- Acronym / sponsor ID
- 2009-08-092
- Conditions
- Hypertrophic Cicatrix
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Seoul National University Hospital, Kyunghee University Medical Center, Inovail
- Study start
- Oct 2010
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 30 Oct 2009 (estimated)
- 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.
Silicone gel is a self-drying silicone polymer that forms thin film after application onto the skin. Because silicone film is a medical device, silicone gel is also regarded as a medical device. Silicone gel has been on the market for many years for the management of scar in the phase of treatment as well as in the phase of prevention. In contrast to other methods that are expensive, invasive or inconvenient, silicone gel is convenient, non-invasive and also reasonably priced. However, the number of well-designed clinicial trials for efficacy and safety are not enough to provide robust evidences in making clinical decisions for scar management options. In a prospective, multi-center, investigator-blind randomized half-split study for patients undergoing cesarean sections, the investigators attempt to provide valid information for the efficacy and safety of silicone gel in the prevention phase of scar.
Detailed description
Prospective subjects will be enrolled in the trial when eligibility screening and informed consent were made. One day after stitch out for cesarean sections, subjects will be asked to start applying silicone gel as the instruction to the randomly designated half of the wound 2 times a day for 12 weeks. Subjects are asked to make visits on week 4, 8, and 12 for efficacy, safety and compliance evaluations. Obstetricians, dermatologists and medical imaging specialists are involved in the trial for the evaluation of efficacy, safety and compliance. Sample size calculation as well as statistical analysis will be conducted by a designated statistician. Study product will be provided by the manufacturer at no cost and patient visits and relevant lab exams will be conducted free of charge.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no treatment | No intervention | Other: no treatmentThe other half of cesarean section wound that is to be left untreated. |
| silicone gel | Experimental | Device: silicone gelRandomly-designated half of cesarean section wound that is to be subject to application ot silicone gel |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Pregnant female of 20-45 in ages equal to or beyond 34th of pregnancy
- Those who understand and agree on the trial conditions
Key exclusion criteria (5 listed)
- Keloid (by present and past medical history)
- Secondary infection, and/or dermatitis in and around c/s wound
- Hypersensitivity to the study agent
- Diabetes
- (Pre)eclampsia
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 |
|---|---|---|
| silicone gelAlso: Dermatixtwice daily application onto designated half of cesarean section wound for 12 weeks | Device | silicone gel |
| no treatmentleft untreated during the study period | Other | no treatment |
Primary outcome
summation of scar scores of modified Vancouver Scar Scale
Time frame: week 12
4 secondary outcomes
summation of scar scores of mVSS 4 and 8 weeks after application
Time frame: weeks 4, 8, 12
scar thickness 12 weeks after application
Time frame: weeks 4, 8, 12
subjective satisfaction 12 weeks after application (VAS)
Time frame: weeks 4, 8, 12
tolerability 4, 8, 12 weeks after application (index3)
Time frame: weeks 4, 8, 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2010.
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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.
Joo-Heung Lee, MD study chair
Samsung Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing silicone gel and no treatment in people with Hypertrophic Cicatrix, run by Samsung Medical Center at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 13 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
summation of scar scores of modified Vancouver Scar Scale (time frame: week 12). 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 13 Dec 2010.