Completed
Phase 4 Study of Scarclinic™ Thin That Treats Surgical Scars.
What is being tested
Scarclinic™ Thin
+ Scarclinic™ Normal
Device
Who is being recruted
From 18 to 55 Years
+8 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: October 2010
Summary
Principal SponsorSeoul National University Hospital
Last updated: April 15, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2010
Actual date on which the first participant was enrolled.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.
Principal SponsorSeoul National University Hospital
Last updated: April 15, 2013
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Any sex
Biological sex of participants that are eligible to enroll.From 18 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
3 inclusion criteria required to participate
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
5 exclusion criteria prevent from participating
general malaise
history of mental disorders
need wound dressing for exudate
taking anticancer drugs or antiphlogistics or steroid
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalScarclinic™ Thin
Group II
Active ComparatorScarclinic™ Normal
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Seoul National Univ. Bundang Hospital
Bundang-gu, South KoreaOpen Seoul National Univ. Bundang Hospital in Google MapsCompletedOne Study Center