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

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


- 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.


- 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


Nasolabial Folds


KOKEN, Atelocollagen Filler


Kangnam St.Mary's Hospital of Catholic University
Korea, Republic of




Sewon Cellontech Co., Ltd.

Results (where available)

View Results


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

Clinical Trials [105 Associated Clinical Trials listed on BioPortfolio]

Post Market Study Evaluating Princess Filler Lidocaine for the Correction of Nasolabial Folds

In this study, eligible subjects with moderate to severe nasolabial folds will be treated with Princess® FILLER Lidocaine and will return for follow-up assessments 2, 4, 24 and 36 weeks a...

Evaluation of the Safety and Efficacy of CosmetaLife™ for the Correction of Nasolabial Folds

This is a randomized, double-blind study to evaluate the safety and effectiveness of CosmetaLife injectable dermal filler for the correction of wrinkles and folds, such as nasolabial folds...

Evaluation of the Effectiveness and Safety of Radiesse for the Correction of Nasolabial Folds in China

The objectives of this study are to evaluate the effectiveness and safety of Radiesse for the correction of nasolabial folds (NLFs)

Long Term Safety and Efficacy Assessment of Hyaluronic Acid Dermal Filler With for the Treatment of Nasolabial Folds

This study evaluates the injection of a hyaluronic acid dermal filler with lidocaine 0.3% in the treatment of nasolabial folds (NLF). Each patient will receive 1 concentration in a NLF (20...

Multicenter Study of the Safety and Effectiveness of Dermal Filler, Belotero®.

This is a study to find out how an investigational product, Belotero®, compares to a second product in people with facial wrinkles, such as nasolabial folds. Nasolabial folds are wrinkle...

PubMed Articles [377 Associated PubMed Articles listed on BioPortfolio]

Relationship Between Midface Volume Deficits and the Appearance of Tear Troughs and Nasolabial Folds.

Understanding interrelationships among aging facial features is important in facial aesthetics as a global treatment approach becomes standard.

Improving Nitrogen and Phosphorus Removal from Reclaimed Water Using a Novel Sulfur/Iron Composite Filler.

In order to improve the ability of denitrification and phosphorus removal from reclaimed water, a novel composite filler was prepared using sulfur powder and sponge iron powder, and a comparative expe...

Topographic anatomy of the infraorbital artery and its clinical implications for nasolabial fold augmentation.

[BACKGROUND]: Understanding the topography of the blood vessels distributed around the nasolabial fold (NLF) region is essential for ensuring the safety of dermal filler injections into the NLF. The p...

Lower Eyelid Reconstruction Using a Nasolabial, Perforator-based V-Y Advancement Flap: Expanding the Utility of Facial Perforator Flaps.

Reconstruction of the lower eyelid represents a unique challenge to the reconstructive surgeon. Studies evaluating the utility of the nasolabial V-Y advancement flap in lower eyelid reconstruction are...

Clockwise and Counterclockwise Le Fort I Movements Influence Nasolabial Morphology Differently.

Le Fort I maxillary advancements are reported to affect nasal proportions. However, there is a no significant data on the three-dimensional nasal changes that occur with differential lateral plane adj...

Medical and Biotech [MESH] Definitions

The vocal apparatus of the larynx, situated in the middle section of the larynx. Glottis consists of the VOCAL FOLDS and an opening (rima glottidis) between the folds.

A skin crease on each side of the face that runs from the outer corners of the nose to the corner of the mouth. It is a common site of PLASTIC SURGERY.

Synthetic resins, containing an inert filler, that are widely used in dentistry.

A form of alveolitis or PNEUMONITIS caused by hypersensitivity to high level of inhaled nitrogen oxides, decomposition products of silage.

Finely powdered native hydrous magnesium silicate. It is used as a dusting powder, either alone or with starch or boric acid, for medicinal and toilet preparations. It is also an excipient and filler for pills, tablets, and for dusting tablet molds. (From Merck Index, 11th ed)

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

Quick Search


Relevant Topic

An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...

Searches Linking to this Trial