Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01848717
Recruitment Status : Unknown
Verified May 2013 by Beom Joon Kim, Chung-Ang University Hosptial, Chung-Ang University College of Medicine.
Recruitment status was:  Recruiting
First Posted : May 7, 2013
Last Update Posted : May 7, 2013
Sponsor:
Collaborator:
HansBiomed Co.,Ltd.
Information provided by (Responsible Party):
Beom Joon Kim, Chung-Ang University Hosptial, Chung-Ang University College of Medicine

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.

Condition or disease Intervention/treatment Phase
Nasolabial Fold Device: MINTLIFT® Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single‐Center, Single Arm, Pre-post Test Design, Open Clinical Study to Evaluate the Efficacy and Safety of MINTLIFT® Group for Nasolabial Fold
Study Start Date : November 2012
Estimated Primary Completion Date : December 2013

Arm Intervention/treatment
Experimental: Lift thread Device: MINTLIFT®



Primary Outcome Measures :
  1. The percentage of the subjects who demonstrated wrinkle improvement to -1 or below in WSRS as determined by an independent evaluator [ Time Frame: 12th week of the application of the test device ]
    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


Secondary Outcome Measures :
  1. The percentage of the subjects who demonstrated wrinkle improvement to -1 or below in WSRS as determined by an independent evaluator [ Time Frame: in the 4th, 8th and 24th week following the application of the device ]
  2. The percentage of the subjects who demonstrated wrinkle improvement to -1 or below in WSRS as determined by the investigator [ Time Frame: in the 4th, 8th, 12th and 24th week following the application of the device ]
  3. The average of the differences between the baseline and the WSRS evaluated by the independent evaluator [ Time Frame: in the 4th, 8th, 12th and 24th week following the application of the test device ]
  4. The average of the differences between the baseline and the WSRS evaluated by the subject [ Time Frame: in the 4th, 8th, 12th and 24th week following the application of the test device ]
  5. The average value of Global Aesthetic Improvement Scale (GAIS) scores as determined by the investigator and the distribution of scores [ Time Frame: in the 12th and 24th week following the application of the test device ]
  6. The average value of GAIS scores as determined by the subject and the distribution of scores [ Time Frame: in the 12th and 24th week following the application of the test device ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848717


Contacts
Layout table for location contacts
Contact: Beom Joon KIM, MD, PhD +82-2-6299-1525 beomjoon74@gmail.com

Locations
Layout table for location information
Korea, Republic of
Chung-Ang University Hospital Recruiting
Seoul, Korea, Republic of
Contact: MIN    +82-2-6299-1525    tonhuk28@naver.com   
Sponsors and Collaborators
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
HansBiomed Co.,Ltd.
Investigators
Layout table for investigator information
Principal Investigator: Beom Joon KIM, MD, PhD Department of Dermatology

Layout table for additonal information
Responsible Party: Beom Joon Kim, Associate Professor, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
ClinicalTrials.gov Identifier: NCT01848717     History of Changes
Other Study ID Numbers: HANS_MINTLIFT_1101
First Posted: May 7, 2013    Key Record Dates
Last Update Posted: May 7, 2013
Last Verified: May 2013