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

Seoul National University Hospital40 enrolled

Overview

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 * 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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hypertrophic Surgical Scar

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

Seoul National Univ. Bundang Hospital

Bundang-gu, Seongnam-si,Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

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.

Time frame: Baseline and 3 months

Secondary Outcomes

Satisfaction for Serviceability

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

Time frame: the end of the 3 month of the treatment

Data from ClinicalTrials.gov

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