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

Primary Purpose

Hypertrophic Surgical Scar

Status

Completed

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Scarclinic™ Thin

Scarclinic™ Normal

About this trial

This is an interventional treatment trial for Hypertrophic Surgical Scar focused on measuring hypertropic scar, Vancouver scar scale, silicon gel sheet

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Seoul National Univ. Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Scarclinic™ Thin

Scarclinic™ Normal

Arm Description

Scarclinic™ Thin

Scarclinic™ Normal

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Satisfaction for Serviceability

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

Full Information

NCT ID

NCT01689857

First Posted

September 13, 2012

Last Updated

April 12, 2013

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01689857

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

October 2010 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertrophic Surgical Scar

Keywords

hypertropic scar, Vancouver scar scale, silicon gel sheet

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Scarclinic™ Thin

Arm Type

Experimental

Arm Description

Scarclinic™ Thin

Arm Title

Scarclinic™ Normal

Arm Type

Active Comparator

Arm Description

Scarclinic™ Normal

Intervention Type

Device

Intervention Name(s)

Scarclinic™ Thin

Intervention Description

Apply Scarclinic™ Thin on the scar and dispense 4 ea.for each participant for 3 month.

Intervention Type

Device

Intervention Name(s)

Scarclinic™ Normal

Intervention Description

Apply Scarclinic™ Normal on the scar and dispense 4 ea.for each participant for 3 month.

Primary Outcome Measure Information:

Title

Change From Baseline in Vancouver Scar Scale Score(VSS) at 3 Months

Description

Time Frame

Baseline and 3 months

Secondary Outcome Measure Information:

Title

Satisfaction for Serviceability

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ChanYoung Heo, Ph.D

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National Univ. Bundang Hospital

City

Bundang-gu

State/Province

Seongnam-si,Gyeonggi-do

ZIP/Postal Code

463-707

Country

Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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