Clinical trial NCT01060943: An Efficacy and Safety Study of TheraFill® Versus KOKEN for 3 Months on Nasolabial Folds
Official title: A Randomized, Multicenter, Prospective, Paired Comparison of the Efficacy and Safety of TheraFill® Versus KOKEN for 3 Months on Nasolabial Folds
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nasolabial Folds
Keywords: injectable collagen filler
correction of wrinkles and folds
enrolled : 73
withdrawal : 4
ongoing : 0
completed : 69
Lead sponsor: Sewon Cellontech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2010-02-02
Enrollment: 73
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Those who agreed to this treatment and signed the Informed Consent Form
2. Those who are 20 years old or more and desire to take correction of nasolabial folds
3. 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
4. Those whose Wrinkle Severity Rating Scale (WSRS) is more than 2 points at least

Exclusion Criteria:

1. Subjects or their families who currently have or have the history of autoimmune disease or collagen vascular disease
2. Those who had the history of anaphylactic response
3. Those who are sensitive to implant
4. Those who are sensitive to lidocaine or other amide anesthesia
5. Those who are sensitive to porcine protein
6. Those who are sensitive to control device
7. 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
8. Those who are pregnant or lactating, or expect pregnancy
9. Those who have inflammatory skin disease on the injection area
10. Those who are judged by the subinvestigator to be improper for this study due to mental disease etc.

Primary outcomes:
measure: Efficacy: Wrinkle Severity Rating Scale - Primary endpoint
timeFrame: At screening period, 2, 4 and 12 weeks after last injection
measure: Efficacy: An assessment of the degree of improvement based on the judgement of patients
timeFrame: At screening period, 2, 4 and 12 weeks after last injection
measure: Efficacy: An assessment of the degree of improvement based on the judgement of the Investigators
timeFrame: At screening period, 2, 4 and 12 weeks after last injection
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangnam St.Mary's Hospital of Catholic University
state: Seo-cho
Study officials:
affiliation: St.Mary's Hospital of Catholic University
name: Jong Won Lee, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: