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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Hypertrophic Surgical Scar

Intervention / Treatment
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* Device: Scarclinic™ Thin
* Device: Scarclinic™ Normal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: need wound dressing for exudate wound infection general malaise history of mental disorders taking anticancer drugs or antiphlogistics or steroid

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Scarclinic™ Thin<br>Scarclinic™ Thin | Device: Scarclinic™ Thin<br>* Apply Scarclinic™ Thin on the scar and dispense 4 ea.for each participant for 3 month.<br>|
| Active Comparator: Scarclinic™ Normal<br>Scarclinic™ Normal | Device: Scarclinic™ Normal<br>* Apply Scarclinic™ Normal on the scar and dispense 4 ea.for each participant for 3 month.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. 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. | Baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertropic scar, Vancouver scar scale, silicon gel sheet