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Completed

NCT Number: NCT01689857

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

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Key information

Conditions

Hypertrophic Surgical Scar

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National Univ. Bundang Hospital

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Scarclinic™ Thin

Device

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

Scarclinic™ Normal

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 21, 2012
Registry last updated
Apr 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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