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

NCT01848717 | Unknown

• 1 other identifier: HANS_MINTLIFT_1101
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The percentage of the subjects who demonstrated wrinkle improvement to -1 or below in WSRS as determined by an independent evaluator

  The percentage of the subjects within the test group who demonstrated wrinkle improvement to -1 or below in WSRS in the 12th week following the application of the device in comparison to the condition prior to the application (12th week- prior to application) as determined by an independent evaluator

  12th week of the application of the test device

Secondary Outcomes (6)

• The percentage of the subjects who demonstrated wrinkle improvement to -1 or below in WSRS as determined by an independent evaluator

  in the 4th, 8th and 24th week following the application of the device

• The percentage of the subjects who demonstrated wrinkle improvement to -1 or below in WSRS as determined by the investigator

  in the 4th, 8th, 12th and 24th week following the application of the device

• The average of the differences between the baseline and the WSRS evaluated by the independent evaluator

  in the 4th, 8th, 12th and 24th week following the application of the test device

• The average of the differences between the baseline and the WSRS evaluated by the subject

  in the 4th, 8th, 12th and 24th week following the application of the test device

• The average value of Global Aesthetic Improvement Scale (GAIS) scores as determined by the investigator and the distribution of scores

  in the 12th and 24th week following the application of the test device

Study Arms (1)

Lift thread

EXPERIMENTAL

Device: MINTLIFT®

Interventions

MINTLIFT® DEVICE

Lift thread

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Chung-Ang University Hosptial, Chung-Ang University College of Medicine: lead
• HansBiomed Co.,Ltd.: collaborator

Study Sites (1)

Chung-Ang University Hospital

Seoul, South Korea

RECRUITING

Study Officials

• Beom Joon KIM, MD, PhD

  Department of Dermatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beom Joon KIM, MD, PhD

CONTACT

+82-2-6299-1525; beomjoon74@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 3, 2013
• First Posted: May 7, 2013
• Study Start: November 1, 2012
• Primary Completion: December 1, 2013
• Last Updated: May 7, 2013

Record last verified: 2013-05

Locations

KR (1)