An Efficacy and Safety Study of TheraFill® Versus KOKEN for 3 Months on Nasolabial Folds

NCT01060943 | Completed Phase 3 DMC

• 1 other identifier: 01TRF
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

• Investigational Device : TheraFill® (Atelocollagen Dermal Filler)
• Title : A Randomized, Multicenter, Prospective and Paired Comparison of the Efficacy and Safety of TheraFill® versus KOKEN for 3months on Nasolabial Folds
• Sites and investigators :
• The Catholic University of Korea. Kangnam St. Mary's Hospital (#505, Banpo-dong, Seocho-gu, SEOUL)
• The Catholic Univ. of Korea Holy Family Hospital (#2, Sosa-dong, Wonmi-gu, Bucheon-si, Gyeonggi-do)
• Objective : To compare the non-inferiority of TheraFill® with KOKEN for evaluation of the efficacy and safety on Nasolabial Folds for 3months
• Clinical Study Method : Seventy-three subjects who agree to voluntarily participate in the clinical study are randomized to treatment with TheraFill (porcine atelocollagen filler) and KOKEN (bovine atelocollagen filler) in the contralateral fold(NFL). The subjects shall regularly visit the hospital 5 times or more and if subjects take touch-up treatments, the number of visit times will be increased. Treatments shall be repeated at 2 weeks intervals, as required, to achieve "Optimal cosmetic result". Outcomes shall be evaluated by blinded investigators, investigators and subjects at 2,4 and 12 weeks after baseline.
• Subjects : The target number of subjects is 62subjects, and 73 subjects are selected in the screening period in consideration of 15% of dropout rate.

Conditions

Nasolabial Folds

Keywords

injectable collagen filler; correction of wrinkles and folds; enrolled : 73; withdrawal : 4; ongoing : 0; completed : 69

Outcome Measures

Primary Outcomes (3)

• Efficacy: Wrinkle Severity Rating Scale - Primary endpoint

  At screening period, 2, 4 and 12 weeks after last injection

• Efficacy: An assessment of the degree of improvement based on the judgement of patients

  At screening period, 2, 4 and 12 weeks after last injection

• Efficacy: An assessment of the degree of improvement based on the judgement of the Investigators

  At screening period, 2, 4 and 12 weeks after last injection

Study Arms (2)

KOKEN(collagen)

ACTIVE COMPARATOR

atelocollagen filler

Device: KOKEN

TheraFill

EXPERIMENTAL

atelocollagen filler

Device: Atelocollagen Filler

Interventions

KOKEN DEVICE

atelocollagen filler 1ml pre-filled syringe. 3% atelocollagen is dissolved in PBS. Inject several times every 2 weeks or more weeks. Total amount should be limited up to 25ml per an year.

Also known as: KOKEN ATELOCOLLAGEN FILLER

KOKEN(collagen)

Atelocollagen Filler DEVICE

1ml pre-filled syringe. 3% atelocollagen is dissolved in PBS. Inject several times every 2 weeks or more weeks. Total amount should be limited up to 25ml per an year.

Also known as: TheraFill ATELOCOLLAGEN FILLER

TheraFill

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those who agreed to this treatment and signed the Informed Consent Form
• Those who are 20 years old or more and desire to take correction of nasolabial folds
• Those who have an intention of refraining from other cosmetic treatment(other filler injection, laser or chemical peeling, Botox injection or wrinkle reduction) during the clinical study period
• Those whose Wrinkle Severity Rating Scale (WSRS) is more than 2 points at least

You may not qualify if:

• Subjects or their families who currently have or have the history of autoimmune disease or collagen vascular disease
• Those who had the history of anaphylactic response
• Those who are sensitive to implant
• Those who are sensitive to lidocaine or other amide anesthesia
• Those who are sensitive to porcine protein
• Those who are sensitive to control device
• Those who have taken soft tissue augmentation, laser or cosmetic facial surgery to improve the injection area in 6 months before participation in the clinical study
• Those who are pregnant or lactating, or expect pregnancy
• Those who have inflammatory skin disease on the injection area
• Those who are judged by the subinvestigator to be improper for this study due to mental disease etc.

Sponsors & Collaborators

• Sewon Cellontech Co., Ltd.: lead

Study Sites (1)

Kangnam St.Mary's Hospital of Catholic University

Seoul, Seo-cho, South Korea

Location

Study Officials

• Jong Won Lee, Ph.D

  St.Mary's Hospital of Catholic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 21, 2010
• First Posted: February 2, 2010
• Study Start: May 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: February 2, 2010

Record last verified: 2010-02

Locations

KR (1)