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

NCT01060943 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2010-02-02

No results posted yet for this study

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

Interventions

DEVICE

KOKEN

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.

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.

Sponsors & Collaborators

  • Sewon Cellontech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Jong Won Lee, Ph.D · St.Mary's Hospital of Catholic University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-01-31
Completion
2009-01-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01060943 on ClinicalTrials.gov