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

April 12, 2013 updated by: Chan-Yeong Heo, Seoul National University Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seongnam-si,Gyeonggi-do
      • Bundang-gu, Seongnam-si,Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National Univ. Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction for Serviceability
Time Frame: 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
the end of the 3 month of the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: ChanYoung Heo, Ph.D, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

September 13, 2012

First Submitted That Met QC Criteria

September 17, 2012

First Posted (Estimate)

September 21, 2012

Study Record Updates

Last Update Posted (Estimate)

April 15, 2013

Last Update Submitted That Met QC Criteria

April 12, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-1004-048-004
  • 06-2010-049 (Other Grant/Funding Number: ILDONG Pharmaceutical CO. LTD.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertrophic Surgical Scar

Clinical Trials on Scarclinic™ Thin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kenya

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe