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

2014-08-27 03:16:14 | BioPortfolio

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.

Description

- Evaluation Criteria And Analysis Method :

1. Efficacy - Evaluate total 3 times : 2, 4 and 12 weeks after last injection. In efficacy evaluation data, for difference in WSRS improvement ratio, normality test on the ratio is used, and for the other evaluation variables, statistical hypothesis test is conducted by using t-test, Wilcoxon rank-sum test, Chi-square test, and ANOVA for repeatedly measured data according to the nature of data.

1. Wrinkle Severity Rating System - It is ranged from 1 point (absent) to 5 points (extreme), and WSRS scores are compared baseline(pre-injection period) with every visits.

2. Evaluation of subject's improvement - It is ranged from 1 point (worse) to 5 points (much improved). A degree of improvement to which the subject decides upon every visit is evaluated, compared to the screening period (baseline).

3. Evaluation of investigator's improvement - It is ranged from 1 point (worse) to 5 points (much improved). A degree of improvement to which the investigator decides upon every visit is evaluated, compared to the screening period (baseline).

2. Safety The analysis of safety evaluation data is conducted through descriptive statistics using the causal relationship between outbreak frequency and the devices .

1. Subjective adverse events : Uncomfortable sense after TheraFill® injection

2. Objective adverse events : Investigator shall observe and evaluate adverse events such as edema, redness, tenderness, pain, bruise, itching, nodule and others at injected site after injection

- Evidence : 1. Photographs At screening period, injection, 2, 4 and 12 weeks after injection and upon an adverse event, the photograph results of the front and side shall be attached to the Case Report Form and utilized as objective reference data.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Conditions

Nasolabial Folds

Intervention

KOKEN, Atelocollagen Filler

Location

Kangnam St.Mary's Hospital of Catholic University
Seoul
Seo-cho
Korea, Republic of

Status

Completed

Source

Sewon Cellontech Co., Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:14-0400

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