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

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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

Tracking Information
First Submitted Date  ICMJE May 3, 2013
First Posted Date  ICMJE May 7, 2013
Last Update Posted Date May 7, 2013
Study Start Date  ICMJE November 2012
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2013)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2013)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate the Efficacy and Safety of MINTLIFT® Group for Nasolabial Fold
Official Title  ICMJE A Single‐Center, Single Arm, Pre-post Test Design, Open Clinical Study to Evaluate the Efficacy and Safety of MINTLIFT® Group for Nasolabial Fold
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Nasolabial Fold
Intervention  ICMJE Device: MINTLIFT®
Study Arms  ICMJE Experimental: Lift thread
Intervention: Device: MINTLIFT®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 3, 2013)
62
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01848717
Other Study ID Numbers  ICMJE HANS_MINTLIFT_1101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Beom Joon Kim, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Study Sponsor  ICMJE Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Collaborators  ICMJE HansBiomed Co.,Ltd.
Investigators  ICMJE
Principal Investigator: Beom Joon KIM, MD, PhD Department of Dermatology
PRS Account Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP