CClinicalTrials.gg
Status unknownNCT01848717Updated May 7, 2013

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

An interventional study of MINTLIFT® in Nasolabial Fold, sponsored by Chung-Ang University Hosptial, Chung-Ang University College of Medicine. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2013-05-07.

Sponsored by Chung-Ang University Hosptial, Chung-Ang University College of Medicine · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2013), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Not applicable
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Nasolabial Fold
03

In context

Lead sponsor

Chung-Ang University Hosptial, Chung-Ang University College of Medicine is the lead sponsor of 25 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
62 participants (estimated)

Study arms

  • Experimental
    Lift thread

    Device: MINTLIFT®

Interventions

  • DeviceMINTLIFT®
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What researchers measure

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

    Time frame: 12th week of the application of the test device

Secondary outcomes

  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

07

Study locations

1 of 1 sites recruiting
  • Chung-Ang University Hospital
    Seoul, Korea, Republic of
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01848717
Lead sponsor
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Collaborators
HansBiomed Co.,Ltd.
Responsible party
Beom Joon Kim (Associate Professor, Chung-Ang University Hosptial, Chung-Ang University College of Medicine) — Principal investigator
First posted
May 7, 2013
Start date
Nov 2012
Primary completion
Dec 2013 (estimated)
Last update
May 7, 2013

Study contacts

Beom Joon KIM, MD, PhD
Contact
beomjoon74@gmail.com
+82-2-6299-1525
Beom Joon KIM, MD, PhD
principal investigator · Department of Dermatology
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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