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| ID | Type | Description | Link |
|---|---|---|---|
| 06-2010-049 | Other Grant/Funding Number | ILDONG Pharmaceutical CO. LTD. |
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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
For evaluating the efficacy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scarclinic™ Thin | Experimental | Scarclinic™ Thin |
|
| Scarclinic™ Normal | Active Comparator | Scarclinic™ Normal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scarclinic™ Thin | Device | Apply Scarclinic™ Thin on the scar and dispense 4 ea.for each participant for 3 month. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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.
We assess total score that are minimum score is 0 and maximum is 18. The lowest score means the best scar condition. | Baseline and 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction for Serviceability | Satisfaction for serviceability will be performed at the end of the 3 month when the treatment was completed by using Questionaire | the end of the 3 month of the treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ChanYoung Heo, Ph.D | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National Univ. Bundang Hospital | Bundang-gu | Seongnam-si,Gyeonggi-do | 463-707 | South Korea |
In this study, we had no run-in period before study was commenced and there were no subjects who drop out before enrollment and randomization to groups.
This study was conducted at Seoul National University Bundang hospital. Forty subjects were recruited from May, 2010 to April,2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Scarclinic™ Thin | Scarclinic™ Thin applied on the surgical scar for 12weeks |
| FG001 | Scarclinic™ Normal | Scarclinic™ Normal applied on the surgical scar for 12weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Scarclinic™ Thin | Scarclinic™ Thin applied on the surgical scar for 12weeks |
| BG001 | Scarclinic™ Normal | Scarclinic™ Normal applied on the surgical scar for 12weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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.
We assess total score that are minimum score is 0 and maximum is 18. The lowest score means the best scar condition. | All participants for whom Vancouver Scar Scale measurements were recorded at Baseline and 3 months. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 3 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Scarclinic™ Thin | Scarclinic™ Thin applied on the surgical scar for 12weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| itching sense | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chanyeong Heo | Seoul National University Bundang Hospital | 82317877222 | lionheo@snu.ac.kr |
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| Scarclinic™ Normal | Device | Apply Scarclinic™ Normal on the scar and dispense 4 ea.for each participant for 3 month. |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Scarclinic™ Thin applied on the surgical scar for 12weeks |
| OG001 | Scarclinic™ Normal | Scarclinic™ Normal applied on the surgical scar for 12weeks |
|
|
| Secondary | Satisfaction for Serviceability | Satisfaction for serviceability will be performed at the end of the 3 month when the treatment was completed by using Questionaire | Not Posted | the end of the 3 month of the treatment |
| 0 |
| 20 |
| 12 |
| 20 |
| EG001 | Scarclinic™ Normal | Scarclinic™ Normal applied on the surgical scar for 12weeks | 0 | 20 | 9 | 20 |
| redness | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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