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

Seoul National University

Status: Completed

Conditions: Hypertrophic Surgical Scar

Treatments: Device: Scarclinic™ Thin; Device: Scarclinic™ Normal

Study type: Interventional

Funder types: Other

Identifiers

NCT01689857

06-2010-049 (Other Grant/Funding Number)

E-1004-048-004

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Scarclinic™ Thin

Experimental group

Description:

Scarclinic™ Thin

Treatment:

Device: Scarclinic™ Thin

Scarclinic™ Normal

Active Comparator group

Description:

Scarclinic™ Normal

Treatment:

Device: Scarclinic™ Normal