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

Not Applicable

Completed

• Conditions: Hypertrophic Surgical Scar
• Interventions: Device: Scarclinic™ Thin; Device: Scarclinic™ Normal

• Registration Number: NCT01689857
• Lead Sponsor: Seoul National University Hospital

Brief 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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2012-07
• Study Completion: 2012-08
• Study First Submitted: 2012-09-13
• Study First Submitted QC: 2012-09-17
• Study First Posted: 2012-09-21
• Results First Submitted: 2012-12-03
• Status Verified: 2013-04
• Results First Submitted QC: 2013-04-12
• Last Update Submitted: 2013-04-12
• Results First Posted: 2013-04-15
• Last Update Posted: 2013-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Scarclinic™ Thin	Scarclinic™ Thin	Scarclinic™ Thin
Scarclinic™ Normal	Scarclinic™ Normal	Scarclinic™ Normal

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Vancouver Scar Scale Score(VSS) at 3 Months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National Univ. Bundang Hospital; 🇰🇷 Bundang-gu, Seongnam-si,Gyeonggi-do, Korea, Republic of