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

NCT01689857 | Completed Results

• 2 other identifiers: E-1004-048-00406-2010-049
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertrophic Surgical Scar

Keywords

hypertropic scar, Vancouver scar scale, silicon gel sheet

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Satisfaction for Serviceability

  the end of the 3 month of the treatment

Study Arms (2)

Scarclinic™ Thin

EXPERIMENTAL

Scarclinic™ Thin

Device: Scarclinic™ Thin

Scarclinic™ Normal

ACTIVE COMPARATOR

Scarclinic™ Normal

Device: Scarclinic™ Normal

Interventions

Scarclinic™ Thin DEVICE

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

Scarclinic™ Thin

Scarclinic™ Normal DEVICE

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

Scarclinic™ Normal

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National Univ. Bundang Hospital

Bundang-gu, Seongnam-si,Gyeonggi-do, 463-707, South Korea

Location

Results Point of Contact

• Title: Dr. Chanyeong Heo
• Organization: Seoul National University Bundang Hospital

lionheo@snu.ac.kr

82317877222

Study Officials

• ChanYoung Heo, Ph.D

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 13, 2012
• First Posted: September 21, 2012
• Study Start: October 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: August 1, 2012
• Last Updated: April 15, 2013
• Results First Posted: April 15, 2013

Record last verified: 2013-04

Locations

KR (1)