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

Hypertrophic Surgical Scar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01689857
• Other study ID #: E-1004-048-004
• Secondary ID: 06-2010-049
• Status: Completed
• Phase: N/A
• First received: September 13, 2012
• Last updated: April 12, 2013
• Start date: October 2010
• Est. completion date: August 2012

Study information

• Verified date: April 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertrophic Surgical Scar

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National Univ. Bundang Hospital	Bundang-gu	Seongnam-si,Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 3 months	No
Secondary	Satisfaction for Serviceability	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	No