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

NCT ID: NCT01689857

Last Updated: 2013-04-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertrophic Surgical Scar

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Scarclinic™ Thin

Scarclinic™ Thin

Group Type EXPERIMENTAL

Scarclinic™ Thin

Intervention Type DEVICE

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

Scarclinic™ Normal

Scarclinic™ Normal

Group Type ACTIVE_COMPARATOR

Scarclinic™ Normal

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Scarclinic™ Thin

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

Intervention Type DEVICE

Scarclinic™ Normal

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Chan-Yeong Heo

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

ChanYoung Heo, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Seoul National Univ. Bundang Hospital

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

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

06-2010-049

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

E-1004-048-004

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.