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

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

Status

Unknown

Conditions

Nasolabial Fold

Treatments

Device: MINTLIFT®

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01848717

HANS_MINTLIFT_1101

Details and patient eligibility

About

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.

Enrollment

62 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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