Status:
UNKNOWN
Evaluate the Efficacy and Safety of MINTLIFT® Group for Nasolabial Fold
Lead Sponsor:
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Collaborating Sponsors:
HansBiomed Co.,Ltd.
Conditions:
Nasolabial Fold
Eligibility:
All Genders
20+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01848717
Start Date
November 1 2012
Last Update
May 7 2013
Active Locations (1)
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1
Chung-Ang University Hospital
Seoul, South Korea