Hypertrophic Surgical ScarNCT01689857

Clinical Trial to Evaluate the Safety and Efficacy of Scarclinic™ Thin in Surgical Scars

A study testing Scarclinic™ Thin and Scarclinic™ Normal in people with Hypertrophic Surgical Scar, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Compare the efficacy and safety of Scarclinic™Thin and Scarclinic™ Normal for the treatment of surgical scars. Participant: 40 Treatment period : 3 months Medical device: Scarclinic™Thin , Scarclinic™ Normal Randomization: Table of random number Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Hypertrophic Surgical Scar
What is being tested?: Scarclinic™ Thin and Scarclinic™ Normal
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteSouth Korea
Study dates: Oct 2010to Aug 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Patient who aged more than 18 years and less 55 years
Patient who has a surgical scar that is not over 3 months after the surgery
Patient who sign informed consent form for the study

Who cannot join

need wound dressing for exudate
wound infection
general malaise
history of mental disorders
taking anticancer drugs or antiphlogistics or steroid

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Seoul National Univ. Bundang Hospital
Bundang-gu, Seongnam-si,Gyeonggi-do, 463-707

Other trials in South Korea

About this study

Official title: Phase 4 Study of Scarclinic™ Thin That Treats Surgical Scars.

Compare the efficacy and safety of Scarclinic™Thin and Scarclinic™ Normal for the treatment of surgical scars.

Participant: 40 Treatment period : 3 months Medical device: Scarclinic™Thin , Scarclinic™ Normal Randomization: Table of random number

Read the detailed description

For evaluating the efficacy

The investigator check Vancouver Scar Scale at 1 and 3 month after application to evaluate vascularity, pigmentation, elasticity, height, pain and itchiness
The participant filled out survey included questions regarding convenience in use at 1 and 3 month after application.

Conditions: Hypertrophic Surgical Scar
Being tested: Scarclinic™ Thin, Scarclinic™ Normal
Keywords: hypertropic scar, Vancouver scar scale, silicon gel sheet

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Scarclinic™ ThinDevice
Apply Scarclinic™ Thin on the scar and dispense 4 ea.for each participant for 3 month.
Scarclinic™ NormalDevice
Apply Scarclinic™ Normal on the scar and dispense 4 ea.for each participant for 3 month.

Study groups in NCT01689857
Study group	Role	What they receive
Scarclinic™ Thin	Experimental	Scarclinic™ Thin Receives: Device: Scarclinic™ Thin
Scarclinic™ Normal	Active comparator	Scarclinic™ Normal Receives: Device: Scarclinic™ Normal

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Vancouver Scar Scale Score(VSS) at 3 Months
Scar assessment will be performed at the beginning of the treatment, and at the end of the 3 month when the treatment is completed by using the Vancouver scar scale.VSS assesses 6 variables.
- vascularity(range from normal(0 point) to purple(3point)
- pigmentation(range from normal(0 point) to hyper-pigmentation(3point)
- pliability(range from normal(0 point) to contracture(5point)
- height (range from flat(0 point) to above 5mm(3point)
- pain(range from none(0 point) to Require medication(2point)
- itchiness(range from none(0 point) to Require medication(2point)
We assess total score that are minimum score is 0 and maximum is 18. The lowest score means the best scar condition.
Measured: Baseline and 3 months

Secondary outcomes (1)

Satisfaction for Serviceability
Satisfaction for serviceability will be performed at the end of the 3 month when the treatment was completed by using Questionaire
Measured: the end of the 3 month of the treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2010Aug 2012

First posted21 Sep 2012 (estimated)
Study startOct 2010
Primary completionJul 2012
Study completionAug 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hypertrophic Surgical ScarStudies of the same condition, open and under way.
More trials run by Seoul National University HospitalThe 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01689857
Sponsor's protocol ID: E-1004-048-004
Other IDs: 06-2010-049
Status last verified: Apr 2013
First submitted: 13 Sep 2012
Last updated: 15 Apr 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Surgical Dressing Study Comparing SYLKE vs Other Common Incisional Dressings Following Abdominoplasty/Panniculectomy Patients
Hypertrophic Surgical Scar, Medical Adhesive Related Skin Injury
RecruitingEarly Phase 1
Zinc Oxide Versus Petrolatum Following Skin Surgery
Surgical Incision, Surgery--Complications
Recruiting
A Self-Controlled Clinical Study of Fast-Absorbable Versus Slow-Absorbable Sutures Applied in Ultra Tension-Reducing Suture Technique
Ultra Tension-Reducing Suture Technique
Not yet recruitingObservational study
Plasma Therapy for Scar Management
Wound Healing
Enrolling by invitation
Preoperative Silicone Ointment and Wound Healing
Wound Heal, Scar

All Hypertrophic Surgical Scar trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 4 Study of Scarclinic™ Thin That Treats Surgical Scars.
ClinicalTrials.gov ID: NCT01689857
Acronym / sponsor ID: E-1004-048-004
Conditions: Hypertrophic Surgical Scar
Keywords: hypertropic scar, Vancouver scar scale, silicon gel sheet
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Seoul National University HospitalUniversity, hospital or other
Study start: Oct 2010
Primary completion: Jul 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 21 Sep 2012 (estimated)
Results: Posted 15 Apr 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Compare the efficacy and safety of Scarclinic™Thin and Scarclinic™ Normal for the treatment of surgical scars.

Participant: 40 Treatment period : 3 months Medical device: Scarclinic™Thin , Scarclinic™ Normal Randomization: Table of random number

Detailed description

For evaluating the efficacy

The investigator check Vancouver Scar Scale at 1 and 3 month after application to evaluate vascularity, pigmentation, elasticity, height, pain and itchiness
The participant filled out survey included questions regarding convenience in use at 1 and 3 month after application.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Scarclinic™ Thin	Experimental	Device: Scarclinic™ ThinScarclinic™ Thin
Scarclinic™ Normal	Active comparator	Device: Scarclinic™ NormalScarclinic™ Normal

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Patient who aged more than 18 years and less 55 years
Patient who has a surgical scar that is not over 3 months after the surgery
Patient who sign informed consent form for the study

Key exclusion criteria (5 listed)

need wound dressing for exudate
wound infection
general malaise
history of mental disorders
taking anticancer drugs or antiphlogistics or steroid

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
Scarclinic™ ThinApply Scarclinic™ Thin on the scar and dispense 4 ea.for each participant for 3 month.	Device	Scarclinic™ Thin
Scarclinic™ NormalApply Scarclinic™ Normal on the scar and dispense 4 ea.for each participant for 3 month.	Device	Scarclinic™ Normal

Primary outcome

Change From Baseline in Vancouver Scar Scale Score(VSS) at 3 Months
Time frame: Baseline and 3 months
Scar assessment will be performed at the beginning of the treatment, and at the end of the 3 month when the treatment is completed by using the Vancouver scar scale.VSS assesses 6 variables. * vascularity(range from normal(0 point) to purple(3point) * pigmentation(range from normal(0 point) to hyper-pigmentation(3point) * pliability(range from normal(0 point) to contracture(5point) * height (range from flat(0 point) to above 5mm(3point) * pain(range from none(0 point) to Require medication(2point) * itchiness(range from none(0 point) to Require medication(2point) We assess total score that are minimum score is 0 and maximum is 18. The lowest score means the best scar condition.

1 secondary outcome

Satisfaction for Serviceability
Time frame: the end of the 3 month of the treatment

Results and safety

Results posted to the registry on 15 Apr 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Scarclinic™ Thin	20	15
Scarclinic™ Normal	20	18

Primary outcome: Change From Baseline in Vancouver Scar Scale Score(VSS) at 3 Months

Time frame: Baseline and 3 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Scarclinic™ Thin n = 15	Scarclinic™ Normal n = 18
Value	-3.80 (3.02)	-2.61 (2.63)

Population analysed: All participants for whom Vancouver Scar Scale measurements were recorded at Baseline and 3 months.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Scarclinic™ Thin	0 of 20 (0%)	12 of 20 (60%)	Not reported
Scarclinic™ Normal	0 of 20 (0%)	9 of 20 (45%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hypertrophic Surgical Scar

Not yet recruiting
Surgical Dressing Study Comparing SYLKE vs Other Common Incisional Dressings Following Abdominoplasty/Panniculectomy Patients
Hypertrophic Surgical Scar, Medical Adhesive Related Skin Injury
RecruitingEarly Phase 1
Zinc Oxide Versus Petrolatum Following Skin Surgery
Surgical Incision, Surgery--Complications
Recruiting
A Self-Controlled Clinical Study of Fast-Absorbable Versus Slow-Absorbable Sutures Applied in Ultra Tension-Reducing Suture Technique
Ultra Tension-Reducing Suture Technique
Not yet recruitingObservational study
Plasma Therapy for Scar Management
Wound Healing
Enrolling by invitation
Preoperative Silicone Ointment and Wound Healing
Wound Heal, Scar

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.

ChanYoung Heo, Ph.D principal investigator

Seoul National University Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Scarclinic™ Thin and Scarclinic™ Normal in people with Hypertrophic Surgical Scar, run by Seoul National University Hospital at 1 site 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 3 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: finished, as of the sponsor's last update on 15 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in Vancouver Scar Scale Score(VSS) at 3 Months (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01689857.

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 15 Apr 2013.