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

Nasolabial Fold Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01848717
• Other study ID #: HANS_MINTLIFT_1101
• Status: Recruiting
• Phase: N/A
• First received: May 3, 2013
• Last updated: May 3, 2013
• Start date: November 2012

Study information

• Verified date: May 2013
• Source: Chung-Ang University Hospital
• Contact: Beom Joon KIM, MD, PhD
• Phone: +82-2-6299-1525
• Email: beomjoon74[@]gmail.com
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nasolabial Fold

Intervention

Device:
• MINTLIFT®

Locations

Country	Name	City	State
Korea, Republic of	Chung-Ang University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Chung-Ang University Hospital	HansBiomed Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	The average value of GAIS scores as determined by the subject and the distribution of scores		in the 12th and 24th week following the application of the test device	No