Evaluate the Efficacy and Safety of MINTLIFT® Group for Nasolabial Fold

NCT ID: NCT01848717

Last Updated: 2013-05-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30

Brief Summary

The objective of this clinical test is to verify the safety and efficacy of MINTLIFT®, used for the purpose of improving the appearance of the nasolabial fold on both sides of the face.

Conditions

Nasolabial Fold

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lift thread

Group Type: EXPERIMENTAL

MINTLIFT®

Intervention Type: DEVICE

Interventions

MINTLIFT®

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Individuals who desire an improvement in the appearance of the nasolabial fold on both sides of the face and who have a score of 3 or 4 on the Wrinkle Severity Rating Scale (WSRS) at the time of the screening and at the baseline time point
• Individuals who have consented to abstain from any other dermatological procedures or treatments, including treatments for wrinkle reduction in the facial area, during the duration of this clinical test

Exclusion Criteria

• Subjects who have a scar or hypertrophic scar or a history of keloid conditions that may affect the determination of effect
• Subjects allergic to local anesthetics or sleep anesthetics
• Subjects whose ALT/AST ratio is 2.5 times or more greater than the normal upper limit
• Subjects who have been administered an anticoagulant (with the exception of low dosage aspirin (100mg, up to 300mg/day)) within 2 weeks of the date of the screening, or who require an anticoagulant during the period of the clinical test
• Subjects who have been administered systemic corticosteroids or anabolic steroids within two weeks of the date of the screening or who require their administration during the period of the clinical test (note, however, that the administration of inhaled corticosteroids in a standardized dosage is permissible)
• Subjects who have been administered Vitamin E or non-steroidal anti-inflammatory drugs within 1 week of the date of the screening
• Subjects who have used Topical liniments in the facial area (steroids, retinoids: only medical drugs are included in this criteria, with the exclusion of cosmetic products) within 4 weeks of the date of the screening or who plan on continuing usage during the period of the clinical test
• Subjects who have received wrinkle reduction treatment using CaHA within 1 year of the date of the screening
• Subjects who have received wrinkle reduction treatment using collagen or HA filler within 6 months of the date of the screening, or who have received acne treatment, skin regeneration procedures, or cosmetic surgical procedures (including Botox injections) in the facial area
• Subjects who have a permanent skin expanding implant such as Softform or silicon inserted in the facial area
• Subjects who have scars in the facial area requiring treatment that has not healed for a period of 1 year or longer, or who have a scar or trace in the area on which the clinical test device will applied.
• Subjects who have a chronic or recurrent infection or a history of inflammatory disease that may affect this clinical test
• Subjects who have experienced severe allergies such as symptoms of anaphylaxis

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HansBiomed Co.,Ltd.

INDUSTRY

Sponsor Role: collaborator

Chung-Ang University Hosptial, Chung-Ang University College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Beom Joon Kim

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Beom Joon KIM, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Dermatology

Locations

Chung-Ang University Hospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Beom Joon KIM, MD, PhD

Role: CONTACT

beomjoon74@gmail.com

+82-2-6299-1525

Facility Contacts

MIN

Role: primary

tonhuk28@naver.com

+82-2-6299-1525

Other Identifiers

HANS_MINTLIFT_1101

Identifier Type: -

Identifier Source: org_study_id